Not Signed In -
Carbamazepine |
Atretol; Epitol; Tegretol |
Clinical Trial: Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults with Bipolar I Disorder
This study is no longer recruiting patients.
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Extended-release carbamazepine | Phase III |
MedlinePlus related topics: Bipolar Disorder
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: 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
Further Study Details:
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
Expected Total Enrollment: 102
Secondary Outcomes: Time to remission; Clinical Global Impressions Scale - Bipolar Version; HAM-D and MADRS scales for depression
Expected Total Enrollment: 102
Study start: January 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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
More Information
Study ID Numbers: SPD417-306
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150553
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150553
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Atretol (Drug Digest)
- Carbamazepine (Drug Digest)
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