Overview

A Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborator:
Stanley Medical Research Institute
Treatments:
Amphetamine
Cytidine Diphosphate Choline
Criteria
Inclusion Criteria:

- 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 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)