Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence

NCT00223236 | Completed Phase 3 Results

• 1 other identifier: 03T-439
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar type (a psychotic disturbance in which there is a mixture of schizophrenic and manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore if citicoline supplements are associated with greater improvement in symptoms of mania and on memory and cognition (the mental faculty of perception, reasoning, and judgement) in these patients.

Conditions

Mania; Hypomania; Cocaine Abuse; Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• Cocaine Use Determined by Urine Analysis

  Urine drug screens were administered at each visit to detect cocaine in urine. If negative according to urine analysis, it is determined as no cocaine use and if positive, cocaine use. Percentage of participants with no cocaine detected in urine at exit is an outcome measuring treatment effectiveness. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks.

  Biweekly (visit) urine drug screens

Secondary Outcomes (3)

• Inventory of Depressive Symptomatology Self Report (IDS-SR).

  Change in scores between baseline and exit (exit - baseline).

• Young Mania Rating Scale(YMRS).

  Baseline to exit (exit score - baseline score)

• Rey Auditory Verbal Learning Test(RAVLT)

  Change in T scores between baseline and exit (exitT score - baseline T score).

Study Arms (2)

Citicoline

ACTIVE COMPARATOR

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

Drug: Citicoline

Placebo

PLACEBO COMPARATOR

Inactive ingredient matching the active medication in appearance

Drug: Placebo

Interventions

Citicoline DRUG

Citicoline or placebo will be given beginning at one table (500mg)/day with an increase to two tablets (1000mg)/day at week 2, three tablets (1500mg)/day at week 4 and four tablets (2000mg)/day at week 6. Patients will remain on 2000mg/day through week 12. Doses will be decreased if needed due to side effects.

Also known as: Cytidine-5'-diphosphocholine, CDP-choline

Citicoline

Placebo DRUG

Placebo matching active medication in all other aspects.

Also known as: Identical placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ages 18-70 years
• History of mania or hypomania (bipolar I,II, not otherwise specified (NOS) or cyclothymic disorder or schizoaffective disorder/bipolar type)
• Early recovery for cocaine abuse/dependence (between 7 days and 12 weeks of enrollment).
• Any current mood state as indicated by structured diagnostic interview
• No psychotropic medication changes within 7 days prior to enrollment.
• English or Spanish speaking

You may not qualify if:

• Pregnant/nursing woman
• Current or past citicoline therapy
• Active suicidal or homicidal ideation with plan and intent
• Dementia, mental retardation or other severe cognitive impairment
• Severe or life threatening medical condition

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The UT Southwestern Medical Center of Dallas

Dallas, Texas, 75390-8849, United States

Location

MeSH Terms

Conditions

Mania; Cocaine-Related Disorders

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

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

Limitations and Caveats

Low retention rate in the end of study (12 weeks) leading to a potential underestimation of treatment effectiveness.

Results Point of Contact

• Title: E. Sherwood Brown, M.D., Ph.D., Professor
• Organization: The University of Texas Southwestern Medical Center

sherwood.brown@utsouthwestern.edu

214-645-6950

Study Officials

• E. Sherwood Brown, PH.D., M.D.

  The UT Southwestern Medical Center of Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-08

Locations

US (1)