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

• ClinicalTrials.gov Identifier: NCT00377299
• Recruitment Status: Completed
• First Posted: September 18, 2006
• Results First Posted: August 8, 2013
• Last Update Posted: August 8, 2013
• Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Stanley Medical Research Institute
• Information provided by (Responsible Party): University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: September 14, 2006
• First Posted Date: September 18, 2006
• Results First Submitted Date: September 8, 2011
• Results First Posted Date: August 8, 2013
• Last Update Posted Date: August 8, 2013
• Study Start Date: October 2006
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 5, 2013)

Depression Symptoms [ Time Frame: 12 weeks ]

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).

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: July 5, 2013)

• Amphetamine Craving [ Time Frame: 12 Weeks ]
  Visual Analog Scale (VAS) assessing Methamphetamine craving with a 1-100 scale.Higher values on the VAS scale indicate a higher Methamphetamine craving(worse outcome).
• Amphetamine Use [ Time Frame: 12 weeks ]
  Participant reported days per 7-day week of methamphetamine use.
• Hopkins Auditory Verbal Learning Test (HVLT) [ Time Frame: 12 weeks ]
  The Hopkins Auditory Verbal Learning Test (HVLT) is a measure of cognition (memory/recall). Raw scores are derived for Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index. Raw scores are calculated into T-scores. T-scores are standardized scores on each dimension for each type. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean.
• Stroop Color Word Test [ Time Frame: 12 weeks ]
  The Stroop Color Word Test measures the individual's ability to separate the word and color naming stimuli thus the ability to sort information from the environment and selectively react to this information. The scoring is a measure of time to complete 100 items and the numbers of items that can be completed. THe scores are converted into T-scores which have a mean of 50 and a standard deviation of 10.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence
• Official Title: A Double-blind, Placebo-controlled Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Amphetamine Abuse
• Amphetamine Dependence
• Bipolar Disorder
• Major Depressive Disorder

Intervention

• Drug: 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.
• Drug: Placebo
  Placebo matching active medication in all other physical aspects

Study Arms

• Experimental: Citicoline
  Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
  Intervention: Drug: Citicoline
• Placebo Comparator: Placebo
  Placebo matching active medication.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 14, 2006): 60
• Original Enrollment: Same as current
• Actual Study Completion Date: May 2009
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00377299
• Other Study ID Numbers: 052006-27
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Texas Southwestern Medical Center
• Study Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Stanley Medical Research Institute

Investigators

• Principal Investigator: Sherwood Brown, M.D., Ph.D.; University of Texas Southwestern Medical Center

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: July 2013