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Levetiracetam in the Management of Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Keppra, Levetiracetam, Anticonvulsant, Depression, Bipolar Disorder, Affective Disorders, Mood Disorders, Double Blind, Acute Antidepressant Effects

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levetiracetam

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
November 29, 2007
Last Updated
March 27, 2020
Sponsor
Yale University
Collaborators
Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00566150
Brief Title
Levetiracetam in the Management of Bipolar Depression
Official Title
Levetiracetam in the Management of Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Keppra, Levetiracetam, Anticonvulsant, Depression, Bipolar Disorder, Affective Disorders, Mood Disorders, Double Blind, Acute Antidepressant Effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
Flexible dose up to 2500mg per day, for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Flexible dose up to 2500mg per day, for 6 weeks.
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.
Description
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.
Time Frame
Baseline to week 6
Secondary Outcome Measure Information:
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.
Description
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.
Time Frame
Baseline to week 6
Title
Number of Subjects Who Achieve Remission.
Description
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.
Time Frame
Week 6
Title
Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.
Description
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
Time Frame
Baseline to week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zubin Bhagwagar, MD PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17140277
Citation
Muralidharan A, Bhagwagar Z. Potential of levetiracetam in mood disorders: a preliminary review. CNS Drugs. 2006;20(12):969-79. doi: 10.2165/00023210-200620120-00002.
Results Reference
background
PubMed Identifier
21034692
Citation
Saricicek A, Maloney K, Muralidharan A, Ruf B, Blumberg HP, Sanacora G, Lorberg B, Pittman B, Bhagwagar Z. Levetiracetam in the management of bipolar depression: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):744-50. doi: 10.4088/JCP.09m05659gre. Epub 2010 Oct 19.
Results Reference
derived

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Levetiracetam in the Management of Bipolar Depression

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