A Pilot Study of Citicoline Add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence
Information source: University of Texas Southwestern Medical Center
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amphetamine Abuse; Amphetamine Dependence; Bipolar Disorder; Major Depressive Disorder
Intervention: Citicoline (supplement) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s):
Sherwood Brown, M.D., Ph.D., Principal Investigator, Affiliation: UT Southwestern Medical School
Overall contact:
Colleen Fagan, Phone: 214-645-6954, Email: Colleen.Fagan@UTSouthwestern.edu
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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)
Locations and Contacts
Colleen Fagan, Phone: 214-645-6954, Email: Colleen.Fagan@UTSouthwestern.edu
Psychoneuroendocrine Research Program, Dallas, Texas 75390, United States; Recruiting
Additional Information
Starting date: September 2006
Last updated: February 6, 2009
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