Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

Validus Pharmaceuticals102 enrolled

Overview

The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

102

Conditions

Bipolar Disorder

Interventions

Extended-release carbamazepineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * DSM-IV criteria for bipolar I disorder * Screen YMRS score =\> 16 * Women of childbearing potential agree to take adequate precautions against contraception Exclusion Criteria: * Hospitalization required for treatment of psychiatric symptoms * Patients who meet DSM-IV for ultra-rapid cycling * History of serious suicide attempt requiring medical intervention

Outcomes

Primary Outcomes

Score on Young Mania Rating Scale (YMRS) at 12 weeks

Secondary Outcomes

Time to remission

Clinical Global Impressions Scale - Bipolar Version

HAM-D and MADRS scales for depression

Data from ClinicalTrials.gov

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