Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Pilot Study of Citicoline Add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence
This study is currently recruiting participants.
Verified by University of Texas Southwestern Medical Center, September 2006
Sponsors and Collaborators: University of Texas Southwestern Medical Center
Stanley Medical Research Institute
Information provided by: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00377299
  Purpose

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.


Condition Intervention
Amphetamine Abuse
Amphetamine Dependence
Bipolar Disorder
Major Depressive Disorder
Drug: Citicoline (supplement)

MedlinePlus related topics: Bipolar Disorder Depression Dietary Supplements Methamphetamine
Drug Information available for: Amphetamine Amphetamine sulfate Methamphetamine Cytidine diphosphate choline
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: 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

Further study details as provided by University of Texas Southwestern Medical Center:

Estimated Enrollment: 60
Study Start Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377299

Contacts
Contact: Katie Gowen 214-645-6960 Katie.Gowen@UTSouthwestern.edu
Contact: Barry Gabrielson, B.S. 214-645-6967 Barry.Gabrielson@UTSouthwestern.edu

Locations
United States, Texas
Psychoneuroendocrine Research Program Recruiting
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Stanley Medical Research Institute
Investigators
Principal Investigator: Sherwood Brown, M.D., Ph.D. UT Southwestern Medical School
  More Information

Study ID Numbers: 052006-27
Study First Received: September 14, 2006
Last Updated: September 14, 2006
ClinicalTrials.gov Identifier: NCT00377299  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Amphetamine Abuse
Amphetamine Dependence
Bipolar Disorder
Major Depressive Disorder
Citicoline

Study placed in the following topic categories:
Choline
Depression
Bipolar Disorder
Disorders of Environmental Origin
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Methamphetamine
Affective Disorders, Psychotic
Dopamine
Amphetamine-Related Disorders
Mental Disorders
Cytidine Diphosphate Choline
Mood Disorders
Substance-Related Disorders
Psychotic Disorders
Amphetamine

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Nootropic Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics
Physiological Effects of Drugs
Central Nervous System Stimulants
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009