Link Between Serotonin and Depression Questioned
Hypothesis that depression is caused by low serotonin not supported; some evidence shows decrease in serotonin with antidepressant use
Mood Disorders
Novel NMDA Receptor Channel Blocker Fast Tracked for Major Depressive Disorder
The designation is supported by data from a phase 2 study, which showed that REL-1017 produced rapid, robust, and sustained antidepressant effects vs placebo.
Zulresso Indication Expanded to Include Younger Patients With Postpartum Depression
The expanded approval was based on safety data from an open-label study in 20 patients aged 15 to 17 years with postpartum depression.
Trial Evaluating Zuranolone for Postpartum Depression Meets All Endpoints
Zuranolone is an investigational oral neuroactive steroid GABA-A receptor positive allosteric modulator.
New Caplyta Dosage Strengths Approved for Specific Patient Populations
Caplyta is indicated for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorders, as monotherapy and as adjunctive therapy with lithium or valproate.
Igalmi Sublingual Film Approved for Agitation With Schizophrenia, Bipolar Disorder
The approval was based on data from the phase 3 SERENITY I and II studies that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively.
FDA: Safety Concerns With Compounded Ketamine Nasal Spray
The use of compounded ketamine nasal spray for home use may place the patient at risk for serious psychiatric adverse events, misuse, and abuse.
What Legal Duty Do Practitioners Have to Warn Potential Victims of a Patient?
Two years after her husband was killed, Mr Z’s grandmother sued several of the hospital’s physicians.
Caplyta Approved for Bipolar Depression in Adults
The approval was supported by data from two phase 3 studies that evaluated Caplyta as monotherapy and adjunctive therapy with lithium or valproate in adults with bipolar depression.
Negative Allosteric Modulator Gets Fast Track Status for Social Anxiety Disorder
The Company will evaluate BNC210 in patients with SAD in the phase 2 PREVAIL trial.
