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

NCT ID: NCT00377299

Last Updated: 2013-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-05-31

Brief 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.

Detailed Description

Sixty outpatients meeting the inclusion and exclusion criteria will be enrolled after completing an Institutional Review Board (IRB)-approved informed consent process. Baseline evaluation will include a medical and psychiatric history, structured clinical interview for Diagnostic and Statistical Manual (DSM-IV) (SCID), mood assessment with the Inventory of Depressive Symptomatology-Self Report (IDS-C), Young Mania Rating Scale (YMRS), and cognitive assessment with the Hopkins Auditory Verbal Learning Test (HVLT) (similar to the Rey Auditory Verbal Learning Test (RAVLT) but more alternative equivalent versions are available), Stroop and computer assessments including Sternberg Memory Task and the Running Memory Continuous Performance Test. Alternate but equivalent versions of all cognitive tests, except the Stroop, will be used to minimize practice effects with repeated administration. Days and amounts of amphetamine and other substance use will be assessed at each visit with urine drug screens, and through self-report using the timeline follow-back method. Amphetamine, and other drug, craving will be assessed with a visual analogue scales. Citicoline or placebo add-on therapy will be given beginning at one tablet (500mg)/day with an increase to two tablets 1000 mg/day at week 2, three tables 1500 mg/day at week 4 and four tablets 2000 mg/day at week 6.

Conditions

Amphetamine Abuse; Amphetamine Dependence; Bipolar Disorder; Major Depressive Disorder

Keywords

Amphetamine Abuse; Amphetamine Dependence; Bipolar Disorder; Major Depressive Disorder; Citicoline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Citicoline

Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.

Group Type: EXPERIMENTAL

Citicoline

Intervention Type: DRUG

Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. Citicoline or placebo (identical in appearance) add-on therapy was given beginning at one tablet (500mg/day) with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4 and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects.

Placebo

Placebo matching active medication.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching active medication in all other physical aspects

Interventions

Citicoline

Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. Citicoline or placebo (identical in appearance) add-on therapy was given beginning at one tablet (500mg/day) with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4 and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects.

Intervention Type: DRUG

Placebo

Placebo matching active medication in all other physical aspects

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherwood Brown, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Psychoneuroendocrine Research Program

Dallas, Texas, United States

Countries

United States

Other Identifiers

052006-27

Identifier Type: -

Identifier Source: org_study_id