Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2010-12-09Clinical Trial Update: Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients [Phase 3]
A Phase 3 trial assessing the efficacy and safety of quetiapine (Seroquel) and lithium as monotherapy for acute mania in bipolar disorder; t…
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CLINICAL_TRIALS research · 2010-12-09Clinical Trial Update: A Non-interventional Naturalistic Project to Investigate the Effect of the Use of SMS Text Service on Treatment Adherence in Patients Treated With Seroquel® (Quetiapine)
A non-interventional study evaluating whether an SMS text service influenced adherence in patients treated with quetiapine (Seroquel) for bi…
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CLINICAL_TRIALS trial_result · 2010-12-09Clinical Trial Update: Depressive Symptoms in Acute Manic Episode
The document reports on depressive symptoms during acute manic episodes in bipolar disorder in a completed AstraZeneca-sponsored clinical tr…
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FDA approval · 2010-12-06FDA Approved: HALOPERIDOL — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for haloperidol submitted by Zydus Lifesciences Limited.
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CLINICAL_TRIALS trial_result · 2010-12-06Clinical Trial Update: White Matter in Pediatric Bipolar Disorder: A DTI Study
A completed clinical trial investigating white matter differences in pediatric bipolar disorder using diffusion tensor imaging (DTI).
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FDA approval · 2010-12-03FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, LLC.
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FDA approval · 2010-12-03FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)
FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, indicating an updated regulatory ac…
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FDA approval · 2010-12-01FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)
The FDA approved a supplemental application for risperidone (RISPERDAL) from Janssen Pharmaceuticals, Inc., resulting in changes to its labe…
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FDA approval · 2010-12-01FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC. The approval covers the supplemental su…
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FDA approval · 2010-12-01FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.
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FDA approval · 2010-12-01FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for SEROQUEL XR (quetiapine) submitted by AstraZeneca Pharmaceuticals LP.
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FDA approval · 2010-12-01FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)
The FDA approved Janssen's supplemental application for Risperdal M-TAB (risperidone), a supplemental filing related to the M-TAB formulatio…
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FDA label_change · 2010-12-01FDA Approved: ABILIFY — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
The FDA approved a supplemental application for ABILIFY (aripiprazole) submitted by Otsuka America Pharmaceutical, Inc., resulting in change…
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CLINICAL_TRIALS trial_result · 2010-11-25Clinical Trial Update: A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder. [Phase 3]
This entry notes the completion of a Phase 3 trial evaluating risperidone added to mood stabilizers for manic episodes in bipolar disorder, …
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CLINICAL_TRIALS trial_result · 2010-11-25Clinical Trial Update: Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania [Phase 2]
A Phase 2 randomized trial comparing lamotrigine with sodium valproate for mixed mania in bipolar disorder has completed.
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CLINICAL_TRIALS trial_result · 2010-11-09Clinical Trial Update: Assessing the Effectiveness of Acceptance and Commitment Therapy for Distress Following Psychosis [NA]
A completed clinical trial evaluating Acceptance and Commitment Therapy for distress following psychosis has been reported. The study, spons…
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FDA approval · 2010-11-04FDA Approved: LAMOTRIGINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)
FDA approved a supplemental application for lamotrigine from Jubilant Cadista Pharmaceuticals Inc., indicating approved changes to labeling.
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CLINICAL_TRIALS trial_result · 2010-11-01Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder [Phase 3]
This Phase 3 clinical trial evaluated the efficacy and safety of risperidone for the prevention of mood episodes in patients with Bipolar I …
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FDA approval · 2010-10-24FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)
FDA approves a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC.
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FDA approval · 2010-10-24FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)
FDA approved a supplemental application for EQUETRO (carbamazepine) from Validus Pharmaceuticals LLC.
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CLINICAL_TRIALS trial_result · 2010-10-20Clinical Trial Update: A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode [Phase 4]
Phase IV trial evaluating safety and efficacy of combining aripiprazole with lamotrigine for long-term maintenance in Bipolar I disorder wit…
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CLINICAL_TRIALS research · 2010-10-11Clinical Trial Update: Lamotrigine Pregnancy Registry (LAM05)
Update on the Lamotrigine Pregnancy Registry (LAM05) reporting results from pregnancy exposure data in epilepsy and bipolar disorder, sponso…
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CLINICAL_TRIALS trial_result · 2010-09-27Clinical Trial Update: Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression [Phase 2]
Phase 2 trial of Lu AA34893 for bipolar depression was terminated; the document summarizes study efficacy and safety considerations.
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CLINICAL_TRIALS trial_result · 2010-09-20Clinical Trial Update: Management of Index Episode in Patients With Bipolar Disorder Treated by Seroquel XR
A completed clinical trial evaluating management of the index episode in bipolar disorder patients treated with Seroquel XR (quetiapine exte…
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CLINICAL_TRIALS trial_result · 2010-09-10Clinical Trial Update: Transcranial Direct Current Stimulation (tDCS) Augmentation by D-Cycloserine as a Treatment for Depression [Phase 2]
A Phase 2 clinical trial evaluated adding D-cycloserine to transcranial direct current stimulation (tDCS) for depression. The study, includi…