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A Pilot Study of Citicoline Add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence
This study has been completed.
Study NCT00377299   Information provided by University of Texas Southwestern Medical Center
First Received: September 14, 2006   Last Updated: May 8, 2009   History of Changes

September 14, 2006
May 8, 2009
September 2006
May 2009   (final data collection date for primary outcome measure)
Depression Symptoms and Amphetamine Use. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00377299 on ClinicalTrials.gov Archive Site
Amphetamine Craving and Improved Cognition [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
Same as current
 
A Pilot Study of Citicoline Add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence
A Double-Blind, Placebo-Controlled Pilot Study of Citicoline Add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence

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 hospitalization, violence towards self and others, medication non-adherence and cognitive impairment. However, few studies have investigated the treatment of dual-diagnosis patients as substance use is frequently an exclusion criterion in clinical trials of patients with BD. To address this need we have developed a research program that explores the pharmacotherapy of people with BD and substance related-disorders. A potentially very interesting treatment for BD is citicoline. Some data suggest that this supplement may stabilize mood, decrease drug use and craving, and improve memory. We found promising results with citicoline in patients with BD and cocaine dependence. In recent years the use of amphetamine and methamphetamine has become an important public health concern. However, virtually no research has been conducted on the treatment of amphetamine abuse. We propose a double-blind placebo controlled prospective trial of citicoline in a group of 60 depressed outpatients with bipolar disorder, depressed phase or major depressive disorder and amphetamine abuse/dependence, to explore the safety and tolerability of citicoline, and its efficacy for mood symptoms, stimulant use and craving and its impact on cognition. Our goal is to determine which symptoms (e.g. mood, cognition, substance use) citicoline appears to be most effective and estimate effect sizes for future work.

 
 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Amphetamine Abuse
  • Amphetamine Dependence
  • Bipolar Disorder
  • Major Depressive Disorder
Drug: Citicoline (supplement)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women ages 18-70 years
  • Meeting criteria for a current major depressive episode (bipolar I,II, NOS, depressed phase) or major depressive disorder on the 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 Criteria:

  • 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)
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00377299
E.S. Brown, UT Southwestern Medical Center
052006-27
University of Texas Southwestern Medical Center
Stanley Medical Research Institute
Principal Investigator: Sherwood Brown, M.D., Ph.D. UT Southwestern Medical School
University of Texas Southwestern Medical Center
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP