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| 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) |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2006 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Psychoneuroendocrine Research Program | |
| Dallas, Texas, United States, 75390 | |
| Principal Investigator: | Sherwood Brown, M.D., Ph.D. | UT Southwestern Medical School |
More Information
| Responsible Party: | UT Southwestern Medical Center ( E.S. Brown ) |
| Study ID Numbers: | 052006-27 |
| Study First Received: | September 14, 2006 |
| Last Updated: | May 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00377299 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Amphetamine Abuse Amphetamine Dependence Bipolar Disorder Major Depressive Disorder Citicoline |
|
Dopamine Uptake Inhibitors Choline Neurotransmitter Agents Adrenergic Agents Disorders of Environmental Origin Depressive Disorder, Major Affective Disorders, Psychotic Dopamine Mental Disorders Cytidine Diphosphate Choline Substance-Related Disorders Psychotic Disorders Antidepressive Agents |
Nootropic Agents Depression Bipolar Disorder Central Nervous System Stimulants Depressive Disorder Behavioral Symptoms Methamphetamine Amphetamine-Related Disorders Mood Disorders Amphetamine Dopamine Agents Peripheral Nervous System Agents |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Disorders of Environmental Origin Depressive Disorder, Major Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Cytidine Diphosphate Choline Substance-Related Disorders |
Nootropic Agents Disease Depression Bipolar Disorder Sympathomimetics Central Nervous System Stimulants Depressive Disorder Pharmacologic Actions Behavioral Symptoms Methamphetamine Amphetamine-Related Disorders Autonomic Agents Mood Disorders Amphetamine Dopamine Agents |