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

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:
Katie Gowen, Phone: 214-645-6960, Email: Katie.Gowen@UTSouthwestern.edu

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.

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

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)

Katie Gowen, Phone: 214-645-6960, Email: Katie.Gowen@UTSouthwestern.edu

Psychoneuroendocrine Research Program, Dallas, Texas 75390, United States; Recruiting

Starting date: September 2006
Last updated: September 14, 2006