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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-10-31

Brief Summary

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

Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Extended-release carbamazepine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Other Identifiers

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SPD417-308

Identifier Type: -

Identifier Source: org_study_id