Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder

Validus Pharmaceuticals50 enrolled

Overview

The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

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 * Screening YMRS score =\>16 * Women of childbearing potential agree to take adequate precautions against contraception * Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic 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 * Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening

Outcomes

Primary Outcomes

Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment

Secondary Outcomes

YMRS Scale

Clinical Global Impressions Scale - Bipolar Version

HAM-D and MADRS Scales for Depression

Data from ClinicalTrials.gov

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