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

NCT00377299 | Completed Results

• 1 other identifier: 052006-27
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Depression Symptoms

  Inventory of Depressive Symptomatology-Clinician Rated (IDS-C), (a clinician-administered depression scale) is used to assess the severity of depressive symptoms.Scores can range from 0 to 84. The higher the score, the worse the depressive symptoms(worse outcome).

  12 weeks

Secondary Outcomes (4)

• Amphetamine Craving

  12 Weeks

• Amphetamine Use

  12 weeks

• Hopkins Auditory Verbal Learning Test (HVLT)

  12 weeks

• Stroop Color Word Test

  12 weeks

Study Arms (2)

Citicoline

EXPERIMENTAL

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

Drug: Citicoline

Placebo

PLACEBO COMPARATOR

Placebo matching active medication.

Drug: Placebo

Interventions

Citicoline 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.

Citicoline

Placebo DRUG

Placebo matching active medication in all other physical aspects

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Psychoneuroendocrine Research Program

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders; Bipolar Disorder; Depressive Disorder, Major

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Dr. E. Sherwood Brown, M.D., Ph.D.
• Organization: UT Southwestern Medical Center at Dallas

sherwood.brown@utsouthwestern.edu

214-645-6950

Study Officials

• Sherwood Brown, M.D., Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 8, 2013
• Results First Posted: August 8, 2013

Record last verified: 2013-07

Locations

US (1)