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Psychiatry Month in Review: September 2024

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This Month in Review features the approval of trospium chloride capsules (Cobenfy) as well as other clinical trials in the psychiatry field.

September brought a lot of movement in the pipeline, especially with the US Food and Drug Administration (FDA) approving trospium chloride capsules (Cobenfy), formerly KarXT, for schizophrenia on the 26th.

This month in review features studies on discovered associations in the psychiatry field between mental health with irritable bowel syndrome (IBS), low cognitive functioning, and high dose amphetamine. A report was also recently published on the estimated potential demand for FDA-approved psilocybin-assisted therapy (PSIL-AT) for major depressive disorder (MDD) and treatment-resistant depression (TRD).

FDA Approves First Pharmacological Approach for Schizophrenia in 50 Years

FDA Approves Xanomeline and Trospium Chloride (Cobenfy) for Schizophrenia

The FDA announced their approval of xanomeline and trospium chloride capsules (Cobenfy) for treating schizophrenia on September 26, 2024. This antipsychotic medication targets cholinergic receptors rather than dopamine receptors, offering a novel treatment option.

The approval is based on phase 3 EMERGENT trials, which showed significant improvements in schizophrenia symptoms, including positive, negative, and cognitive symptoms. Results indicated a notable reduction in the PANSS total score and long-term benefits, with 75% of participants experiencing a ≥30% symptom improvement after 52 weeks. Unlike previous treatments, xanomeline and trospium chloride capsules do not lead to adverse events such as weight gain and movement disorders.

New Findings on Associations in Psychiatric Research

Causal Links Found Between Schizophrenia, Major Depressive Disorder on IBS

A recent study indicates MDD and schizophrenia have causal effects on IBS, while IBS may also exacerbate MDD. Conducted by investigators led by Wang Fan at Changhai Hospital, this Mendelian randomization analysis is the first to thoroughly examine the causal relationship between these psychiatric disorders and IBS.

The findings support the notion of abnormal brain-gut interactions influencing IBS, highlighting the importance of managing both gastrointestinal and psychiatric symptoms. The study suggests a bidirectional association, where the presence of 1 condition can worsen the other, emphasizing the need for integrated treatment strategies.

Lower Cognitive Functioning Linked to Natural Cause Mortality in Schizophrenia

A recent study found that lower cognitive functioning is significantly associated with an increased risk of natural cause mortality in individuals with schizophrenia. The study revealed that those with cognitive scores below the 50th percentile were more likely to die from natural causes during a median follow-up of 14.4 years. Other identified risk factors included autoimmune disorders, tobacco smoking, and chronic obstructive pulmonary disease. The investigators suggest that poor cognitive functioning may impair patients' ability to recognize health issues, comply with treatments, and communicate effectively with healthcare providers, underscoring the need for interventions to improve cognitive abilities in this population.

Patients on High Dose Amphetamine Face Over 5-Fold Psychosis, Mania Risk

A new study found patients taking high doses of amphetamines, particularly ≥ 30 mg of dextroamphetamine (equivalent to 40 mg of Adderall), face a 5-fold increased risk of developing psychosis or mania. The study used electronic health records to compare psychiatric hospitalization cases.

Results showed a clear dose-response relationship, with greater doses significantly increasing risk. However, methylphenidate did not show the same association. Investigators emphasized the importance of dose consideration when prescribing stimulants, especially for patients at high risk of psychosis or mania.

Q&A with lead investigator Lauren Moran, MD: https://www.hcplive.com/view/the-5-fold-psychosis-mania-risk-on-high-dose-amphetamine-with-lauren-moran-md

Notable Discoveries in the Psychiatry Field

Adding Brief CBT to Inpatient’s Usual Treatment Reduces Suicide Reattempts

A recent study found adding brief cognitive behavioral therapy (CBT) to usual treatment for inpatients admitted for suicidal ideation or behavior reduced post-discharge suicide attempts by 60% and psychiatric readmissions by 71%. The research involved 200 participants who were either given usual care or usual care plus brief CBT.

Those receiving CBT had fewer suicide reattempts and readmissions, particularly patients without substance use disorders. These findings highlight the potential for CBT in suicide prevention.

New Report Estimates Potential Demand of Psilocybin-Assisted Therapy for MDD

A new report estimates the potential demand for psilocybin-assisted therapy (PSIL-AT) in the US for MDD and treatment-resistant depression (TRD). If approved by the FDA, PSIL-AT could benefit millions.

Using clinical trial exclusion criteria, investigators projected that 24% to 62% of patients with MDD or TRD could be eligible for PSIL-AT, amounting to 2.2 to 5.6 million MDD patients and 0.6 to 1.7 million TRD patients. These findings highlight the need for careful planning to ensure equitable access and implementation of PSIL-AT if approved.


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Thumbnail for schizophrenia special report around approval of Cobenfy.
Thumbnail for schizophrenia special report around approval of Cobenfy.
Thumbnail for schizophrenia special report around approval of Cobenfy.
Thumbnail for schizophrenia special report around approval of Cobenfy.
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