Levetiracetam in the Management of Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

Levetiracetam in the Management of Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566150
• Other study ID #: 0508000506
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Est. completion date: August 2008

Study information

• Verified date: August 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Levetiracetam
Flexible dose up to 2500mg per day, for 6 weeks.
• Placebo
Flexible dose up to 2500mg per day, for 6 weeks.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Muralidharan A, Bhagwagar Z. Potential of levetiracetam in mood disorders: a preliminary review. CNS Drugs. 2006;20(12):969-79. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.	Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.	Baseline to week 6
Secondary	Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.	Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60.	Baseline to week 6
Secondary	Number of Subjects Who Achieve Remission.	Remission response is measured as an HDRS-21 total score is less than or equal to 7.; HDRS-21 measures range of depressive symptoms. Endpoint is LOCF.	Week 6
Secondary	Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.	Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill	Baseline to week 6