Clinical trial NCT00223236: Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mania
Hypomania
Cocaine Abuse
Cocaine Dependence
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Cocaine Use Determined by Urine Analysis
timeFrame: Biweekly (visit) urine drug screens
Secondary outcomes:
measure: Inventory of Depressive Symptomatology Self Report (IDS-SR).
timeFrame: Change in scores between baseline and exit (exit - baseline).
measure: Young Mania Rating Scale(YMRS).
timeFrame: Baseline to exit (exit score - baseline score)
measure: Rey Auditory Verbal Learning Test(RAVLT)
timeFrame: Change in T scores between baseline and exit (exitT score - baseline T score).
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The UT Southwestern Medical Center of Dallas
state: Texas
Study officials:
affiliation: The UT Southwestern Medical Center of Dallas
name: E. Sherwood Brown, PH.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: