Bipolar Disorder
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CLINICAL_TRIALS trial_result · 2017-10-26Clinical Trial Update: Internet-Based Interventions for Bipolar Disorder (MoodSwings 2) [NA]
This entry notes a completed study (MoodSwings 2) evaluating internet-based interventions for bipolar disorder, conducted by the University …
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CLINICAL_TRIALS trial_result · 2017-10-13Clinical Trial Update: Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride [Phase 1]
Phase 1 study assessing intra-subject variability in the bioavailability of chlorpromazine hydrochloride. The study is completed and results…
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CLINICAL_TRIALS trial_result · 2017-10-13Clinical Trial Update: Pilot Trial of Peer Support for Bipolar Disorder [NA]
The document reports that a pilot clinical trial of peer support for bipolar disorder has been completed, evaluating peer support as an inte…
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FDA label_change · 2017-10-05FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)
FDA approved a labeling supplement for Depakote Sprinkles (divalproex sodium) submitted by AbbVie.
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FDA label_change · 2017-10-05FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)
FDA approved AbbVie's supplemental application for Depakote (divalproex sodium), leading to changes to the product labeling.
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CLINICAL_TRIALS trial_result · 2017-10-05Clinical Trial Update: Algorithm Guided Treatment Strategies for Bipolar Depression [Phase 4]
A Phase 4 clinical trial evaluating algorithm-guided treatment strategies for bipolar depression.
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CLINICAL_TRIALS trial_result · 2017-10-04Clinical Trial Update: Improving Outcomes for Individuals With Serious Mental Illness and Diabetes [NA]
Clinical trial update on improving outcomes for individuals with serious mental illness and diabetes; study completed with results posted in…
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CLINICAL_TRIALS trial_result · 2017-10-03Clinical Trial Update: Memantine in Bipolar Patients With Alcoholism [Phase 3]
Phase 3 clinical trial update for memantine in bipolar patients with alcoholism is reported, with status currently unknown.
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FDA approval · 2017-09-26FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for quetiapine fumarate from Sun Pharmaceutical Industries, Inc., approving updates to the generic's…
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EMA guidance · 2017-09-26EMA's first public hearing: giving EU citizens a voice to help reduce the risk of valproate
EMA held its first public hearing to involve EU citizens in reducing the risk associated with valproate use, aiming to give patients a voice…
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FDA approval · 2017-09-26FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application to market a generic quetiapine fumarate product from Aurobindo Pharma Limited.
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CLINICAL_TRIALS trial_result · 2017-09-19Clinical Trial Update: Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine [EARLY_Phase 1]
Early-phase clinical trial evaluating D-cycloserine targeting a genetic mutation in glycine metabolism for schizophrenia and bipolar disorde…
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FDA approval · 2017-09-08FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s supplemental application for risperidone, approving a new generic risperidone product.
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CLINICAL_TRIALS trial_result · 2017-09-05Clinical Trial Update: Radiosurgical Neuromodulation for Refractory Depression [NA]
A terminated clinical trial evaluating radiosurgical neuromodulation for refractory bipolar disorder; results posted in 2017.
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CLINICAL_TRIALS trial_result · 2017-08-29Clinical Trial Update: Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania [Phase 4]
Phase 4 trial evaluating quetiapine plus topiramate for reducing cannabis use and managing bipolar mania has completed with posted results.
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CLINICAL_TRIALS trial_result · 2017-08-29Clinical Trial Update: Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders
A completed clinical trial from Massachusetts General Hospital evaluating the effectiveness and cost impact of peer support for mood disorde…
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CLINICAL_TRIALS trial_result · 2017-08-15Clinical Trial Update: Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder [NA]
This clinical trial update reports the completion and results posting of a study on early detection and prevention of mood disorders in chil…
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CLINICAL_TRIALS trial_result · 2017-08-15Clinical Trial Update: Acute Psychotherapy for Bipolar II Depression [Phase 4]
Phase 4 trial update on acute psychotherapy for bipolar II depression; study completed with results posted.
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FDA approval · 2017-08-11FDA Approved: INVEGA — Supplemental Application (Janssen Pharmaceuticals, Inc.)
The FDA approved Janssen's supplemental application for INVEGA (paliperidone), expanding its approved indications.
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CLINICAL_TRIALS trial_result · 2017-08-08Clinical Trial Update: Oral Contraceptive Interaction Study for GW273225 [Phase 1]
Phase 1 oral contraceptive interaction study of GW273225 in bipolar disorder patients was terminated.
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FDA approval · 2017-08-04FDA Approved: ARIPIPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for aripiprazole by Quallent Pharmaceuticals Health LLC, bringing a generic version of the antip…
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CLINICAL_TRIALS trial_result · 2017-07-31Clinical Trial Update: Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder? [Phase 4]
This Phase 4 clinical trial update reports results on whether Risperidone Consta reduces relapse and rehospitalization in bipolar disorder, …
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CLINICAL_TRIALS trial_result · 2017-07-26Clinical Trial Update: Effect of Ketamine vs. Active Placebo on Suicidal Ideation in Depressed Inpatients With Major Depressive Disorder or Bipolar Depression. [EARLY_Phase 1]
An early-phase 1 trial comparing ketamine to an active placebo in depressed inpatients (major depressive disorder or bipolar disorder with d…
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CLINICAL_TRIALS trial_result · 2017-07-25Clinical Trial Update: Prevention of Weight Gain in Early Psychoses [NA]
A completed clinical trial update examining strategies to prevent weight gain in individuals with early psychosis.
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CLINICAL_TRIALS trial_result · 2017-07-24Clinical Trial Update: Asenapine for Bipolar Depression [Phase 2]
A Phase 2 clinical trial of asenapine for bipolar depression sponsored by the University of Cincinnati has been terminated; the snippet does…