The Effectiveness and Mechanisms of Action of App-Based Interventions for Improving Mental Health and Workplace Well-Being: Randomized Controlled Trial

Background: Depression is the most common mental health disorder worldwide and frequently leads to workplace absence. As face-to-face treatment can be difficult to access, app-based interventions are a popular solution, although their effectiveness in working populations and their mechanisms of action are unclear. Deficits in executive function may contribute to the onset and maintenance of depression, and executive function training is proposed to improve symptoms by enhancing executive function. Responders to cognitive behavioral therapy (CBT) show improvements in executive function, suggesting that this may be one mechanism of action. Objective: This study investigated the effectiveness of app-based interventions (executive function or CBT-based) for reducing depressive and anxiety symptoms and improving workplace well-being, and assessed whether changes in executive function mediated improvements. Methods: A total of 228 participants (147 female participants) with mild-to-moderate symptoms of depression and anxiety were recruited online and randomly assigned to a waitlist control group, an executive function training group (NeuroNation app, Synaptikon GmbH), or a self-guided CBT group (Moodfit app, Roble Ridge LLC) for a 4-week intervention period. Participants assigned to the active intervention groups were asked to use their apps a minimum of 21 times during the intervention. Participants completed measures of depressive symptoms, anxiety symptoms, and workplace well-being, and a working memory task at baseline, postintervention, and follow-up (12 weeks). Results: Executive function training reduced anxiety (β=−2.79; =.004) and depressive (β=−2.77; =.02) symptoms at follow-up but not at postintervention, and it did not affect workplace well-being. There were no reductions in depressive or anxiety symptoms in the self-guided CBT group, though workplace well-being was improved at postintervention (β=3.72; =.02) and follow-up (β=4.46; =.02). Improvements in executive function did not mediate intervention-related changes in symptoms or workplace well-being. Self-reported adherence rates were high (executive function training: 48/54, 89%; self-guided CBT: 52/54, 96%), although attrition was high at follow-up (58% missing). Conclusions: These results suggest that app-based executive function training may be effective at managing symptoms of anxiety and depression in a working population, while self-guided CBT apps may improve workplace well-being. However, improving executive function did not appear to be a mechanism of action of either intervention. Trial Registration: ISRCTN 12730006; https://www.isrctn.com/ISRCTN12730006
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Milnacipran continuation during pregnancy in a patient with severe post-traumatic stress disorder and psychotic depression: a case report with 3-year pediatric follow-up

Evidence on milnacipran exposure during pregnancy is sparse, complicating treatment decisions when maternal stability depends on this antidepressant. We report a 31-year-old primigravida with severe post-traumatic stress disorder and a severe major depressive episode with psychotic features in the context of a chronic, difficult-to-treat psychiatric course marked by self-harm, dissociation, and recurrent suicidal behavior. Milnacipran 150 mg/day led to marked clinical improvement before pregnancy. After pregnancy confirmation, treatment was changed to sertraline plus quetiapine because of limited pregnancy safety data, but depressive symptoms and suicidal behavior reemerged within 2 weeks. Milnacipran was therefore re-established after risk-benefit evaluation and shared decision-making, with renewed improvement. Moderate hyperemesis gravidarum during the second trimester led to discontinuation of milnacipran by gestational week 22. Delivery occurred at gestational week 38 via primary cesarean section. No congenital anomalies or neonatal adaptation problems were observed. At 3-year follow-up, pediatric developmental screenings remained within expected limits. This case illustrates the challenge of balancing relapse risk, prior treatment response, and treatment feasibility during pregnancy when evidence for the effective medication is limited.

STAT+: Zap in a cap: How one neurotech startup is using a hat to treat depression

Wake up. Brush your teeth. Wash your face. 

And put on your lifesaving baseball hat.

That’s right. If you have treatment-resistant depression, this could be the regular morning routine in your future. The hat would activate a blueberry-sized device implanted in your skull that sends a pulse of electricity into your brain.

This is Jacob Robinson’s vision — and it got closer to reality on Friday after the Food and Drug Administration approved a request from Robinson’s startup, Motif Neurotech, to start an initial feasibility trial to test the efficacy of their device in treating depression that hasn’t responded to other treatments. Scientists have been zapping brains to alleviate depression for decades through a method called transcranial magnetic stimulation, or TMS. Motif wants to do the same thing, but with a twist.

Continue to STAT+ to read the full story…

StockWatch: Trump Order Lifts Psychedelic Drug Shares

Stocks of most publicly traded psychedelic drug developers jumped when President Donald Trump signed Executive Order 14401, directing the FDA and other federal agencies to accelerate research and improve access to psychedelic drugs, citing their potential as promising treatments for serious mental illnesses.

Among its provisions, the order directs the FDA to provide Commissioner’s National Priority Vouchers (CNPVs) to “appropriate” psychedelic drugs that were granted the agency’s Breakthrough Therapy designation and met the voucher program’s criteria. The FDA’s parent agency, the Department of Health and Human Services (HHS), is required to spend at least $50 million through the Advanced Research Projects Agency for Health (ARPA-H) “to support and partner with” state governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses.

“This is an unmet public health need and potentially promising treatments. That’s why there’s a sense of urgency around this, and why we’re doing it now,” FDA Commissioner Martin A. Makary, MD, said at the ceremony where Trump signed the order. “Applications are about to come in, and this is the perfect timing for this announcement.”

At least one analyst agreed that the timing was right for Washington to spur the development of psychedelic drugs.

“Investor mindshare should rise meaningfully ahead of pot’l approvals in 2027–30,” Andrew Tsai, equity analyst with Jefferies, observed in a research note. “As we approach the first pot’l FDA approval of a psychedelic in 2027, President Trump is providing an official stamp of validation to the class in the form of an executive order, reassuring us that the FDA/HHS/White House’s support of psychedelics is real/actionable (not rhetorical).”

Proving correct

Makary said the FDA planned to issue CNPVs to three serotonin 2a agonists, a class that includes LSD and other psychedelic drugs. While he did not reveal specific companies and drugs by name, market watchers immediately speculated that one of the drugs was COMP360 synthetic psilocybin, the lead clinical candidate of Compass Pathways (NASDAQ: CMPS)—speculation that proved correct when COMP360 won a CNPV on Friday.

COMP360 is expected, according to Tsai, to be the first psychedelic drug to win FDA approval in 2027. In February, Compass announced what it called statistically significant and clinically meaningful data from two Phase III trials assessing COMP360 in treatment-resistant depression (TRD), COMP005 (NCT05624268) and COMP006 (NCT05711940). The data showed positive effects for COMP360 within one day, lasting at least through six months after just one or two doses among those who have a clinically meaningful response.

COMP360 is also in Phase II trials for both PTSD and anorexia nervosa.

Compass fueled speculation about an FDA voucher approval by issuing a statement supporting the executive order: “Today’s announcement aligns regulatory urgency with patient need, and we applaud the Administration for taking this important step forward in accelerating access, without compromising rigorous science.”

Investors celebrated with Compass, whose shares soared 42% from $6.66 to $9.46 on April 20, the first trading day after the order signing. Shares yo-yoed the rest of the week, sliding 7.5% to $8.75 Wednesday before rebounding nearly 5% to $9.15 Thursday and rising another roughly 5% to $9.58 Friday on news of the voucher approval. Year-over-year, Compass shares have more than doubled, soaring about 140% from $5.22 on April 24, 2025.

FDA names additional voucher grantees

The FDA indeed issued three CNPVs on Friday—one to Compass as previously mentioned, one to Usona Institute, a nonprofit medical research organization, for psilocybin for major depressive disorder (MDD), and one to Otsuka Pharmaceutical (Tokyo Stock Exchange: 4578) for methylone (TSND-201) for post-traumatic stress disorder (PTSD). Otsuka is acquiring the methylone program as part of its up-to-$1.225 billion ($700 million upfront) purchase of privately held Transcend Therapeutics, announced last month.

Launched in October by Makary, CNPVs are awarded to drug developers whose work is deemed to address a health crisis in the United States, deliver more innovative cures, address unmet public health needs, and increase domestic drug manufacturing as a national security issue. The vouchers entitle companies to reviews of their final applications within a target timeframe of 1–2 months, rather than the current 10–12 months.

“Ultimately, we do not see the FDA’s issuance of the first set of CNPVs as precluding other psychedelic players from also obtaining CNPVs in the future—so we think the FDA’s action today bodes well for the space broadly,” Tsai wrote after the FDA announced the voucher recipients. “Net-net, the macro backdrop for psychedelics is improving.”

That improvement, Tsai added, reflects Trump’s endorsement of psychedelic drugs, a collaborative FDA, and growing interest in the space by big pharma giants such as Johnson & Johnson (NYSE: JNJ), which generated $1.696 billion in 2025 sales and $468 million in first quarter sales from Spravato (esketamine), an NMDA receptor antagonist indicated for treatment-resistent depression (TRD) and depressive symptoms in adults with MDD with acute suicidal ideation or behavior in conjunction with an oral antidepressant.

The voucher decision hardly budged Otsuka shares, which dipped nearly 1% Friday from ¥10,870 ($68.18) to ¥10,810 ($67.80).

However, Compass was one of several psychedelic drug companies to see their shares surge on news of the executive order.

AtaiBeckley (NASDAQ: ATAI), formed last November by the merger of atai Life Sciences and Beckley Psytech, jumped 22% from $4.03 to $4.90 on April 20, then plateaued the rest of the week, finishing Friday at $4.63 and a 15% one-week gain. AtaiBeckley shares year-over-year have more than tripled, rocketing 204% from $1.53 a year ago Friday.

Definium Therapeutics (NASDAQ: DFTX) shares rose 5% over two days, from $22.68 the Friday before Trump signed the order to $23.84 on Tuesday, but gave back all the week’s gain, finishing Friday at $22.48. Long-range investors have fared better, as Definium shares have more than tripled, zooming 249% from $6.43 on April 24, 2025.

GH Research (NASDAQ: GHRS) shares climbed 17% from $18.34 to $21.50 the first day after the executive order, only to drop 6% the rest of the week, closing Friday at $20.25 and settling for a 10% one-week gain. GH’s shares doubled year-over-year, growing 101% from $9.50 a year ago Friday.

Showing volatility

The executive order wasn’t enough to boost shares of Cybin, which operates under the name Helus Pharma (NASDAQ: HELP). Helus showed the most volatility in the days following the order signing, tumbling 12% from $5.61 to $4.93 on April 20. The drop followed Helus’ announcement that its CEO, Michael Cola, stepped down immediately at the request of its board, succeeded by interim CEO Eric So, while the board carries out a search for a permanent chief executive.

“It’s like they can’t give investors a break,” fumed “SamZaki320” on a Reddit chat board. “The only positive is that the executive order sentiment is pushing back against a total disaster. Not that it’s a good thing, other companies are up double digits.”

Helus shares bounced back 17% to $5.77 Wednesday and dipping 0.35% to $5.75 Thursday despite the company announcing two powerhouse additions to its scientific advisory board—Robert Langer, ScD, the David H. Koch Institute professor at MIT and a co-founder of Moderna (NASDAQ: MRNA); and Stephen Brannan, MD, a neuroscience drug development expert with over 20 years of experience designing and implementing clinical programs for psychiatric and neurological disorders. Shares fell 2% Friday, closing at $5.61.

In a statement, interim CEO So lauded Trump’s order: “The Executive Order reflects growing recognition of the urgent need for new treatment options in serious mental health conditions and the importance of advancing innovative therapies through rigorous, research-based development.”

Looking beyond Washington

Yet So acknowledged that Washington alone can’t advance psych drug development beyond what its science can accomplish: “Policy momentum is meaningful, but the future of this field will ultimately be determined by the strength of the clinical evidence and the ability to deliver safe, reliable treatments at scale.”

As did Helus and Compass, Definium also praised the executive order: “We applaud the Administration’s recognition that psychedelic medicines may represent meaningful new treatment options for patients,” Definium CEO Rob Barrow stated. He cited his company’s clinical development program for DT120 (lysergide tartrate) for conditions that include generalized anxiety disorder (GAD) and MDD.

At the ceremony where he signed the executive order, Trump acknowledged being asked to address psych drug development by podcaster Joe Rogan and others, which the president said led to talks with Makary as well as HHS Secretary Robert F. Kennedy Jr., NIH Director Jay Bhattacharya, MD, PhD, and Mehmet Oz, MD, administrator for the Centers for Medicare & Medicaid Services.

“Research has been going on for quite some time. But usually with things like this, nothing ever happens, no matter how the research ends up. We’re changing that,” Trump said. “Why would we wait three or four years to get it done? Or 10 years? Frankly, let’s get it done immediately—and that’s what happened.”

Leaders and laggards

  • Daiichi Sankyo (Tokyo Stock Exchange: 4568) shares slipped 10% from ¥2,790 ($17.50) to ¥2,499 ($15.67) on Friday after the drug developer announced it was delaying the release of its annual earnings results for the fiscal year that ended March 31, from April 27 to May 11,  “as additional time is required to finalize the financial figures.” May 11 is the day when Daiichi Sankyo plans to release its five-year business plan. “The company is currently reviewing the supply plans for its oncology products portfolio and development pipeline in light of rapidly changing business conditions. As a result, additional deliberation is required to reasonably estimate the amount of loss provisions to be recorded in connection with contracts with contract manufacturers,” Daiichi Sankyo added in a statement.
  • Inhibrx Biosciences (NASDAQ: INBX) shares leaped 37% from $84.08 to $115.09 Wednesday after Reuters reported, citing unnamed sources, that Merck & Co. (NYSE: MRK), Merck KGaA (XETRA: MRK), and Ono Pharmaceutical (Tokyo Stock Exchange: 4528) were in talks with Inhibrx for a joint spinoff of two precision-engineered cancer candidates, INBRX-106 and ozekibart (INBRX-109). The treatments could have a combined value of more than $9 billion if their clinical trials prove successful, the report stated. Inhibrx declined to comment, while the other companies cited did not respond to Reuters queries. INBRX-106 is a hexavalent sdAb-based, OX40-targeting candidate being studied as monotherapy and in combination with Merck & Co.’s cancer immunotherapy blockbuster Keytruda® (pembrolizumab). Ozekibart is a tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. On Tuesday, Inhibrx announced ozekibart showed positive data in a Phase I/II trial (NCT03715933) assessing the drug plus Folfiri in patients with locally advanced or metastatic, unresectable colorectal cancer.
  • Organon (NYSE: OGN) shares surged 31% from $8.60 to $11.26 Friday after the Indian news outlet The Economic Times reported that Sun Pharmaceutical Industries (NSE: SUNPHARMA and BSE: 524715) had submitted a $13 billion offer for the women’s health drug developer spun out of Merck & Co. (NYSE: MRK) in 2021. The deal would be Sun’s largest ever merger-and-acquisition (M&A) deal—if Sun can prevail over at least two other would-be suitors for Organon, German-based private family-owned drug developer Grünenthal, and EQT (Nasdaq Stockholm: EQT), a Swedish-based global investment organization. The latest surge comes two weeks after Organo shares zoomed 28% on an April 10 Economic Times report stating that Sun Pharma had submitted a $12 billion all-cash offer for Organon.
  • Spruce Biosciences (NASDAQ: SPRB) shares tumbled 26% from $69.89 to $51.69 Tuesday after the neurological disorder drug developer priced a $69 million offering of common stock and pre-funded warrants that generated $64.4 million in net proceeds. The offering consisted of 1.15 million shares of common stock priced at $50 per share and pre-funded warrants to purchase 50,000 shares at $49.99 per share. Al shares and pre-funded warrants were sold, and underwriters of the offering exercised in full their option to purchase up to an additional 180,000 shares at the public offering price on Tuesday. “We intend to use the net proceeds from this offering to advance the company’s pre-commercial and launch activities, for planned clinical trials, and for working capital, capital expenditures, and other general corporate purposes,” Spruce stated in its prospectus supplement filed Tuesday. Leerink Partners, Guggenheim Securities, and Oppenheimer & Co. acted as joint book-running managers, while Jones and Craig-Hallum acted as co-managers for the offering.

The post StockWatch: Trump Order Lifts Psychedelic Drug Shares appeared first on GEN – Genetic Engineering and Biotechnology News.

Medication Treatment for Tics and Tourette’s

There are several kinds of medication than can help kids with Tourette’s or another tic disorder. But it’s important to note that not all kids who develop tics need treatment. Tics are very common. They often go away on their own, and they tend to bother parents more than they do the children experiencing them. Drawing attention to them can make them worse. So doing nothing can be the best strategy — at least initially.

Treatment comes into play if tics are upsetting your child, giving them pain, or making it hard for them to function in everyday life — say they’re disrupting class or getting bullied because of their tics.

The first recommended step in treatment is a specialized form of therapy called comprehensive behavioral intervention for tics (CBIT). CBIT is centered on habit reversal training, in which the child learns to recognize when they have an urge to tic and substitute a competing response — an easier, more comfortable, or less noticeable action or behavior that makes the tic impossible. For instance, if a child’s tic is jerking their head to the side, the strategy might be to put their chin down instead.

But if therapy isn’t effective in reducing a child’s tics, medication can help.

Guanfacine and clonidine for tics

First-line medications for Tourette’s and other tic disorders are a class of drugs called alpha-2 agonists, explains Paul Mitrani, MD, PhD, a child and adolescent psychiatrist at the Child Mind Institute. Alpha agonists decrease the release of a neurotransmitter called norepinephrine, which stimulates the nervous system. Alpha agonists serve as a kind of dimmer switch — by calming down the system, they make the urge to tic less frequent, less intense, and by extension, easier to control.

The two alpha-2 agonists usually prescribed for tics are guanfacine and clonidine. Dr. Mitrani reports that he usually starts by prescribing guanfacine because it comes in a longer-acting form (Intuniv), which reduces symptoms for a full 24 hours. Clonidine’s long-acting form (Kapvay) is effective for 12 hours.

Dr. Mitrani adds that there is a new liquid form of clonidine called Onyda XR that lasts 24 hours, but there isn’t yet a strong body of evidence regarding its effectiveness for tics. Onyda XR is FDA-approved for ADHD, as are Kapvay and Intuniv.

While no alpha agonist medications are FDA-approved specifically for tics, Kapvay and Intuniv are frequently used off-label for them. There is ample research on their effectiveness for tics, and they are recommended by clinical practice guidelines.

Some children respond better to several doses of short-acting guanfacine or clonidine, Dr. Mitrani notes, rather than a smoother dose of a long-acting medication. This may be because medication can be timed to peak at times when kids need tic suppression most, such as at school.

Alpha agonists are the preferred first line medications for tic disorders because their side-effects, including drowsiness and low blood pressure, are relatively mild.

Antipsychotics for tics

If alpha agonists aren’t helping, the next step would be to try an antipsychotic medication, which can be more effective for treating tics, Dr. Mitrani notes, but their side effects are potentially more difficult to tolerate.

Aripiprazole (Abilify), which is FDA-approved for tics, is often Dr. Mitrani’s first choice among the antipsychotic medications. Abilify is a second-generation, or atypical, antipsychotic, a group of medications that have fewer side effects than older antipsychotics. Side effects of Abilify can include restlessness, agitation and weight gain.

Haloperidol (Haldol) is also effective for tics, but it’s an older antipsychotic with more side effect concerns, Dr. Mitrani notes. “I’ve only had one patient ever on Haldol, and he tolerated it well and it really helped with his tics when other things did not.”

Risperidone (Risperdal) is another atypical antipsychotic that can help, but its side effects tend to be worse than Abilify. Risperidone can cause more concerning weight gain and metabolic, neurological, and hormonal changes that can be harmful. Sometimes other medications are used to manage the weight gain from antipsychotics.

When kids with tics also have ADHD

More than three-quarters of kids diagnosed with a tic disorder also have another disorder. When a child has multiple disorders, a clinician will want to evaluate which is causing the child the most difficulty and prioritize treating that.

The most common co-occurring disorder with tics is ADHD. “If tics are the bigger problem, we would start with treating them,” says Dr. Mitrani. “If the ADHD is the bigger problem, which it typically is, we usually treat that first.”

In the past, it was recommended that children with tics and ADHD avoid stimulant medication, based on research that showed it made tics worse. But newer studies counter that finding, Dr. Mitrani notes, concluding that the old research was based on very high doses of amphetamine-based medications. To lower the risk of exacerbating tics, he recommends starting kids with ADHD and tics on methylphenidate-based medication.

“If your child is starting a stimulant,” he adds, “and you see worsening of tics — and it’s clearly related to when the stimulant is in their system — the best approach might be a lower dose of stimulant combined with guanfacine or clonidine.”

One advantage to that combination, he notes, is that kids with ADHD who have behavior problems can benefit from the guanfacine or clonidine being active in the mornings before the stimulant starts working and in the evenings when it’s out of their system.

Kids with other co-occurring disorders

When children with tics have other co-occurring disorders, such as anxiety, OCD, or depression, treating them with medication needs to be done very carefully, Dr. Mitrani says. Since children are typically not bothered by the tics themselves, it’s almost always the other disorder that is more problematic for them.  And, he adds, when the other problems cause distress, it can make the tics worse.

For anxiety, OCD, and depression, the first-line medication treatment is an antidepressant. Antidepressants can actually help alleviate tics indirectly, since they reduce anxiety. “Stress increases tics, so if there is significant anxiety and you treat the anxiety, the tics may get better,” Dr. Mitrani says. “And then maybe you don’t need the guanfacine or clonidine. But again, it depends on what the co-occurring disorders are and what’s the bigger problem for the child.”

Monitoring medication for tics

Due to the waxing and waning nature of tics, it can be challenging to see the full effect of medication and other interventions. It is important to give medication enough time to work, Dr. Mitrani notes, typically a few weeks, to see if the overall pattern, frequency, and severity of tics has improved. And children who are being treated should continue to be monitored regularly for any changes, as tics can recur or worsen, especially when a child is excited, tired, or experiencing more stress.

Most children with tics see a natural improvement or even resolution of tics as they progress through adolescence. If there seems to be a long-standing improvement, it is appropriate to consider reducing or stopping medication, especially if the child is experiencing side effects, Dr. Mitrani notes. If tics continue and are causing distress, it is important to keep treating them.

A child going off any of these medications — alpha agonists or antipsychotics — should do so gradually, by having their dose reduced over weeks or even longer, to avoid unpleasant or dangerous side effects of sudden withdrawal.

The post Medication Treatment for Tics and Tourette’s appeared first on Child Mind Institute.

Associations of psychological distress, gaming motives and internet gaming disorder in adolescents: a network analysis

Background and objectiveThe rapid popularization of the Internet among Chinese adolescents has resulted in the emergence of a public major concern known as Internet Gaming Disorder (IGD). As demonstrated by previous studies, an association has been demonstrated among emotional distress, gaming motives and IGD. Nevertheless, the specific pathways connecting these constructs remain to be elucidated. The present study aims to explore the network structure characterizing the interactions among these three constructs and to identify potential targets for psychological interventions.MethodsThis was a cross-sectional survey conducted in city of Hangzhou. A total of 3,795 middle school students were included in the analysis. The 21-item Depression Anxiety Stress Scale (DASS-21), the Motives for Online Gaming Questionnaire (MOGQ), and the Chinese version of the Ten-Item Internet Gaming Disorder Test (IGDT-10) were used to assess emotional distress, gaming motives and IGD symptoms, respectively. Network analyses were performed using R4.5.1 software to explore the interrelationships among emotional distress, gaming motives and IGD symptoms, and identify the core symptoms and bridge symptoms.ResultsIn the depression combined network model, the presence of bridge symptoms was indicated by no initiative (D2), gaming for escape or mood relief (IGD8) and fantasy motive (fan). In anxiety combined network model, the bridge symptoms included coping motive(cop), gaming for escape or mood relief (IGD8), withdrawal (IGD2), mouth dryness (A1), and fear of embarrassment (A4). The bridge symptoms in the stress combined network model were gaming for escape or mood relief (IGD8), difficulty winding down (S1), withdrawal (IGD2), nervous energy expenditure (S3), and coping motive (cop).ConclusionThe present study explored complex network structure among psychological distress, gaming motivation, and IGD. and suggested fantasy and coping motive as bridges connecting psychological distress and IGD. Besides, our research identified no initiative, mouth dryness, difficulty winding down, fear of embarrassment, and nervous energy expenditure as the best targets for intervention to reduce IGD.

STAT+: FDA to speed up review of three psychedelics as mental health treatments

The Food and Drug Administration will accelerate its review of psychedelic drugs developed by Compass Pathways, the Usona Institute, and Transcend Therapeutics for mental health disorders, as part of the Trump administration’s plan to boost access to the controversial yet promising medications.

The agency will grant priority review vouchers specifically to Compass’ psilocybin product for treatment-resistant depression, Usona’s similar medicine for major depressive disorder, and an MDMA-like treatment for post-traumatic stress disorder from Transcend. 

The FDA identified the medications receiving the vouchers, but not the companies developing them. Compass, Usona, and Transcend confirmed they received vouchers.

Continue to STAT+ to read the full story…

<![CDATA[Definium’s CMO says FDA talks stay aligned with their plans for advancing DT120 ODT for the treatment of depression, anxiety, and now PTSD.]]>
<![CDATA[In this CME article, learn how depression hides in organ failure, transplants, neurologic disease, and hormonal shifts—plus screening tips and safer treatment choices.]]>

Vagus nerve stimulation as an anti-inflammatory therapy for maternal immune activation-induced alterations in offspring microglia and neurodevelopment

Autism spectrum disorder (ASD) is a common neurodevelopmental disorder caused by a combination of genetic and environmental factors. With the increasing prevalence of ASD diagnosis, it is crucial to understand the mechanisms behind preventable causes, such as prenatal infections, and look for possible routes to improve outcomes. For example, maternal immune activation (MIA), the process by which immunogens that enter the maternal system lead to a maternal inflammatory response, has been well established as associated with increased ASD diagnosis. However, the mechanisms have not been fully elucidated and the options for targeting MIA as a preventative measure are uncertain. The maternal cytokine response is considered a crucial mechanism underlying MIA-induced neurodevelopmental changes, with key contributing cytokines, which include interleukin (IL)-6 and IL-17a. These cytokines can be produced in the maternal periphery and placenta, leading to the transmission of maternal cytokines into the fetal brain and causing upregulation of endogenous production. In the fetal brain, IL-6 and IL-17a act on microglia, the innate immune cells of the central nervous system, to further induce pro-inflammatory cytokine production. Furthermore, microglia alter fetal brain neurocircuitry, leading to lifelong, ASD-like dysregulation. The vagus nerve, the primary nerve of the parasympathetic nervous system, may serve as a target for intervention. The cholinergic anti-inflammatory pathway can be targeted by vagus nerve stimulation (VNS) and can lead to the downregulation of peripheral cytokines. This review is intended to summarize the cytokine-related mechanisms of MIA, the role of fetal microglia in dysregulation, and to assess the potential for VNS as a preventative treatment measure for MIA-induced alterations.