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

A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150553

Enrollment

102

Registered

2005-09-08

Start date

2005-01-31

Completion date

2005-10-31

Last updated

2007-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Brief summary

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.

Interventions

DRUGExtended-release carbamazepine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Score on Young Mania Rating Scale (YMRS) at 12 weeks	—

Secondary

Measure	Time frame
Time to remission	—
Clinical Global Impressions Scale - Bipolar Version	—
HAM-D and MADRS scales for depression	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026