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Sponsors and Collaborators: |
University of Texas Southwestern Medical Center Stanley Medical Research Institute |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00377299 |
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 |
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Amphetamine Abuse Amphetamine Dependence Bipolar Disorder Major Depressive Disorder |
Drug: Citicoline (supplement) |
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 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Katie Gowen | 214-645-6960 | Katie.Gowen@UTSouthwestern.edu |
Contact: Barry Gabrielson, B.S. | 214-645-6967 | Barry.Gabrielson@UTSouthwestern.edu |
United States, Texas | |
Psychoneuroendocrine Research Program | Recruiting |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Sherwood Brown, M.D., Ph.D. | UT Southwestern Medical School |
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 |
Amphetamine Abuse Amphetamine Dependence Bipolar Disorder Major Depressive Disorder Citicoline |
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 |
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 |