Status:
COMPLETED
A Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Amphetamine Abuse
Amphetamine Dependence
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Bipolar disorder (BD) is a common and severe psychiatric illness. Drug and alcohol abuse are very common in people with BD and other mood disorders and are associated with increased rates of hospitali...
Detailed Description
Sixty outpatients meeting the inclusion and exclusion criteria will be enrolled after completing an Institutional Review Board (IRB)-approved informed consent process. Baseline evaluation will include...
Eligibility Criteria
Inclusion
- Men and women ages 18-70 years
- Meeting criteria for a current major depressive episode (bipolar I,II, not otherwise specified (NOS)
- , depressed phase) or major depressive disorder on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) with a duration of at least 4 weeks
- Meeting criteria for amphetamine abuse or dependence with use within 14 days prior to baseline
- No psychotropic medication changes within 14 days prior to study entry
Exclusion
- Pregnant or nursing women
- Current citicoline therapy
- Active suicidal or homicidal ideation with plan and intent
- Dementia, mental retardation or other severe cognitive impairment that might interfere with the informed consent process
- Currently incarcerated at a prison or jail
- Severe or life threatening medical condition (e.g. terminal cancer, congestive heart failure)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00377299
Start Date
October 1 2006
End Date
May 1 2009
Last Update
August 8 2013
Active Locations (1)
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1
Psychoneuroendocrine Research Program
Dallas, Texas, United States, 75390