Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2015-06-23Clinical Trial Update: Smoking Cessation for Veterans With Severe and Persistent Mental Illness [Phase 2, Phase 3]
This is a Phase 2/3 clinical trial results update from the US Department of Veterans Affairs on smoking cessation for veterans with severe a…
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FDA approval · 2015-06-19FDA Approved: LAMOTRIGINE EXTENDED RELEASE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for Lamotrigine Extended Release, adding an extended-release formulation to the approved lamotrigine…
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FDA label_change · 2015-06-17FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Geodon (ziprasidone) filed by Viatris Specialty LLC, resulting in a labeling update.
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CLINICAL_TRIALS trial_result · 2015-06-12Clinical Trial Update: Cognitive Enhancement in Bipolar Disorder [Phase 4]
Phase 4 clinical trial assessing cognitive enhancement in bipolar disorder completed; results posted in 2015.
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FDA approval · 2015-06-08FDA Approved: LITHIUM CARBONATE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved a generic lithium carbonate product from Alembic Pharmaceuticals Inc. via an original ANDA.
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CLINICAL_TRIALS trial_result · 2015-06-03Clinical Trial Update: Bipolar Research Study Using MR Imaging
A bipolar disorder MRI research study sponsored by Washington University Early Recognition Center has completed.
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CLINICAL_TRIALS withdrawal · 2015-06-01Clinical Trial Update: An Evaluation of Divalproex vs. Olanzapine for Alcohol Abuse Relapse Prevention in Patients With Bipolar Disorder [Phase 4]
Phase 4 trial evaluating divalproex versus olanzapine for preventing alcohol relapse in patients with bipolar disorder was withdrawn.
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FDA approval · 2015-05-29FDA Approved: DIVALPROEX SODIUM — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's generic divalproex sodium product through an Original Application (ANDA 203730).
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CLINICAL_TRIALS trial_result · 2015-05-27Clinical Trial Update: Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692) [Phase 3]
Long-term safety extension results for asenapine in Bipolar I Disorder participants who completed the prior Phase 3 protocol P05691 (P05692)…
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CLINICAL_TRIALS trial_result · 2015-05-21Clinical Trial Update: A Study of Varenicline for Prevention of Relapse to Smoking in Patients With Schizophrenia or Bipolar Disorder [Phase 4]
Phase 4 trial evaluating varenicline to prevent relapse to smoking in patients with schizophrenia or bipolar disorder; study completed with …
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CLINICAL_TRIALS trial_result · 2015-05-21Clinical Trial Update: Effect of Quetiapine on Brain Activity Patterns in Patients With Heightened Risk of Bipolar Disorder [NA]
A clinical trial update investigates the effect of quetiapine on brain activity patterns in individuals at heightened risk for bipolar disor…
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FDA label_change · 2015-05-18FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline; the action updates the product labeling.
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FDA approval · 2015-05-18FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC. The action supplements the original…
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FDA approval · 2015-05-18FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for Lamictal ODT (lamotrigine) submitted by GlaxoSmithKline LLC. The approval concerns the supplemen…
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FDA approval · 2015-05-11FDA Approved: LITHOBID — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Lithobid (lithium carbonate) submitted by ANI Pharmaceuticals, Inc.
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FDA label_change · 2015-05-11FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for DIVALPROEX SODIUM (Divalproex Sodium) from Zydus Pharmaceuticals USA Inc., resulting in labeling…
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CLINICAL_TRIALS withdrawal · 2015-05-08Clinical Trial Update: Identifying Predictors of Bipolar Disorder Relapse During Pregnancy and the Postpartum Period
Clinical trial update indicates that the NIMH study on predictors of bipolar disorder relapse during pregnancy and the postpartum period has…
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CLINICAL_TRIALS trial_result · 2015-04-29Clinical Trial Update: A Brief Community Linkage Intervention for Dually Diagnosed Individuals [NA]
Completed clinical trial update on a community linkage intervention for individuals with dual diagnosis, including schizophrenia/psychotic d…
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CLINICAL_TRIALS trial_result · 2015-04-29Clinical Trial Update: Effectiveness of Cognitive Behavioral Therapy for Treating Depression in People With Bipolar I Disorder [NA]
A completed clinical trial evaluated the effectiveness of cognitive behavioral therapy for depressive symptoms in people with bipolar I diso…
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CLINICAL_TRIALS withdrawal · 2015-04-28Clinical Trial Update: Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder [Phase 2]
Phase 2 study evaluating the Medical Information Device #1 (MIND1) for adherence, safety, and tolerability in schizophrenia or Bipolar I dis…
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FDA approval · 2015-04-28FDA Approved: ARIPIPRAZOLE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved Alembic's original ANDA for aripiprazole, a generic version of the antipsychotic.
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FDA approval · 2015-04-28FDA Approved: ARIPIPRAZOLE — Original Application (Exelan Pharmaceuticals, Inc.)
FDA approved a generic aripiprazole tablet under ANDA205064 for Exelan Pharmaceuticals, authorizing sale for the same indications as the bra…
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CLINICAL_TRIALS trial_result · 2015-04-24Clinical Trial Update: Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691) [Phase 3]
A Phase 3 fixed-dose safety and efficacy study evaluating asenapine for acute manic or mixed episodes in Bipolar I disorder has completed, w…
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FDA approval · 2015-04-23FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited under an ANDA.
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CLINICAL_TRIALS trial_result · 2015-04-20Clinical Trial Update: Maintenance Treatment of Bipolar Depression [Phase 4]
Phase 4 clinical trial update reports completion and posting of results for maintenance treatment of bipolar depression, conducted by The Un…