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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00223236
First received: September 15, 2005
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Mania
Hypomania
Cocaine Abuse
Cocaine Dependence
Drug: Citicoline
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Trial of Citicoline add-on Therapy in Patients With a History of Mania or Hypomania and Cocaine Abuse/Dependence

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Cocaine Use Determined by Urine Analysis [ Time Frame: Biweekly (visit) urine drug screens ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Inventory of Depressive Symptomatology Self Report (IDS-SR). [ Time Frame: Change in scores between baseline and exit (exit - baseline). ] [ Designated as safety issue: No ]
    The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. The each item has a 4-likert scale, 0 to 3, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. 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 tudy period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).

  • Young Mania Rating Scale(YMRS). [ Time Frame: Baseline to exit (exit score - baseline score) ] [ Designated as safety issue: No ]
    The YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal and and 4 or 8 =most abnormal. The total possible score is 0 to 60, 0 being no symptom and 60 the worst symptom. The higher the score, the worse the mania symptoms are. 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. The outcome was measured by change in scores between baseline and exit (exit - baseline).

  • Rey Auditory Verbal Learning Test(RAVLT) [ Time Frame: Change in T scores between baseline and exit (exitT score - baseline T score). ] [ Designated as safety issue: No ]
    The RAVLT consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. The total score is the total number of words recalled through the five trials. Normative RAVLT T-scores was used. the higher T score, the better memory. 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. The outcome was measured by change in RAVLT T scores between baseline and exit (exit - baseline).


Enrollment: 44
Study Start Date: July 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Citicoline
Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
Drug: Citicoline
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.
Other Names:
  • Cytidine-5'-diphosphocholine
  • CDP-choline
Placebo Comparator: Placebo
Inactive ingredient matching the active medication in appearance
Drug: Placebo
Placebo matching active medication in all other aspects.
Other Name: Identical placebo

Detailed Description:

Forty-four outpatients meeting the inclusion and exclusion criteria were enrolled after completing an Institutional Review Board (IRB)-approved informed consent process. Baseline evaluation included a medical and psychiatric history, structured diagnostic interview using Diagnostic and Statistical Manual (DSM)-IV criteria, mood assessment with the Inventory of Depressive Symptomatology-Self Report (IDS-SR), Young Mania Rating Scale (YMRS), and cognitive assessment with the Rey Auditory Verbal Learning Test (RAVLT). Alternate but equivalent versions of the RAVLT were used to minimize practice effects with repeated administration. Cocaine use was assessed at each biweekly visit with urine drug screens. Citicoline or placebo was given beginning at one tablet (500 mg)/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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223236

Locations
United States, Texas
The UT Southwestern Medical Center of Dallas
Dallas, Texas, United States, 75390-8849
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: E. Sherwood Brown, PH.D., M.D. The UT Southwestern Medical Center of Dallas
  More Information

No publications provided

Responsible Party: Sherwood Brown, professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00223236     History of Changes
Other Study ID Numbers: 03T-439
Study First Received: September 15, 2005
Results First Received: July 8, 2013
Last Updated: August 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cocaine-Related Disorders
Bipolar Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders
Cytidine Diphosphate Choline
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014