N/A
N=35
Levetiracetam in the Management of Bipolar Depression
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT00566150 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6. — -2.7647; -4; -3.4259; -6.5875 score on scale — p=0.29
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Levetiracetam (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6. |
-2.7647; -4; -3.4259; -6.5875; -2.1243; -6.3625 | 0.29 |
| SECONDARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6. |
-3.2941; -2.7333; -5.2319; -7.256; -3.384; -9.0417 | 0.07 |
| SECONDARY Number of Subjects Who Achieve Remission. |
0; 4; 17; 11 | .038 sig |
| SECONDARY Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6. |
-0.2941; -0.4667; -0.3186; -0.6956; -0.1984; -0.7753 | 0.79 |
Summary
A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.
Eligibility Criteria
Inclusion Criteria
- DSM-IV diagnosis of bipolar disorder
- Presence of a current major depressive episode on the SCID
- Score of 17 or great on the HDRS
- Capable of giving voluntary written consent
Exclusion Criteria
- Significant current substance dependence/abuse within 3 months preceding the trial
- Active suicidal ideation
- Pregnant/lactating mothers
- Significant medical history
Data sourced from ClinicalTrials.gov (NCT00566150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.