Manic Episode
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CLINICAL_TRIALS research · 2026-03-19Clinical Trial Update: A Study of Spoken Language in Mania [NA]
This clinical trial update reports the completion of a study investigating spoken language in mania in individuals with Bipolar I Disorder.
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CLINICAL_TRIALS research · 2025-12-16Clinical Trial Update: Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS [NA]
A clinical trial is assessing whether ketosis affects the signs and symptoms of schizophrenia and bipolar-related disorders, with recruitmen…
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CLINICAL_TRIALS research · 2025-07-01Clinical Trial Update: Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania [Phase 3]
A Phase 3 clinical trial is evaluating lumateperone for acute treatment of mania in bipolar disorder and is currently recruiting.
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FDA approval · 2025-01-16FDA Approved: HALOPERIDOL LACTATE — Supplemental Application (Mylan Institutional LLC)
FDA granted a supplemental approval for HALOPERIDOL LACTATE to Mylan Institutional LLC, issuing a supplemental application for this generic …
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CLINICAL_TRIALS trial_result · 2020-02-10Clinical Trial Update: A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder [Phase 3]
A Phase 3 trial evaluated brexpiprazole versus placebo for acute manic episodes in Bipolar I Disorder; results have been posted.
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CLINICAL_TRIALS trial_result · 2020-01-02Clinical Trial Update: A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder [Phase 3]
Phase 3 trial comparing brexpiprazole to placebo for acute manic episodes in Bipolar I Disorder has completed; results posted.
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FDA approval · 2018-09-10FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved chlorpromazine hydrochloride under an original application from Amneal Pharmaceuticals; approved indications include schizophre…
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CLINICAL_TRIALS trial_result · 2018-07-31Clinical Trial Update: Observational Post-Authorisation Safety Study of Asenapine (Sycrest)
The document reports the completion of an observational post-authorization safety study evaluating the safety of asenapine (Sycrest) in mani…
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CLINICAL_TRIALS trial_result · 2012-07-17Clinical Trial Update: Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder. [Phase 4]
Phase 4 trial results evaluating the effectiveness of quetiapine XR in controlling manic symptoms in bipolar disorder have been completed, w…
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CLINICAL_TRIALS trial_result · 2011-01-28Clinical Trial Update: A Study of the Effectiveness and Safety of Risperidone Compared With Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder, and the Maintenance of Anti-manic Effectiveness of Risperidone Compared With Haloperidol [Phase 3]
Phase 3 study comparing risperidone to placebo for acute manic episodes in Bipolar I Disorder and assessing maintenance against haloperidol;…
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CLINICAL_TRIALS trial_result · 2011-01-24Clinical Trial Update: A Study of the Effectiveness and Safety of Risperidone as add-on Therapy to Mood Stabilizers in the Treatment of Manic Episodes Associated With Bipolar Disorder [Phase 3]
Phase 3 trial evaluating risperidone added to mood stabilizers for manic episodes in bipolar disorder completed, assessing effectiveness and…
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CLINICAL_TRIALS trial_result · 2011-01-14Clinical Trial Update: A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder [Phase 3]
This document reports the completion of a Phase 3 trial comparing risperidone to placebo for the treatment of manic or mixed episodes in Bip…
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CLINICAL_TRIALS trial_result · 2009-03-25Clinical Trial Update: Phase 3 /Seroquel SR Acute Mania Monotherapy - US [Phase 3]
Phase 3 trial evaluating quetiapine extended-release (Seroquel SR) as monotherapy for acute mania in bipolar disorder has completed.