A Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence
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|ClinicalTrials.gov Identifier: NCT00377299|
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : August 8, 2013
Last Update Posted : August 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Amphetamine Abuse Amphetamine Dependence Bipolar Disorder Major Depressive Disorder||Drug: Citicoline Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
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.
Placebo Comparator: Placebo
Placebo matching active medication.
Placebo matching active medication in all other physical aspects
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377299
|United States, Texas|
|Psychoneuroendocrine Research Program|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Sherwood Brown, M.D., Ph.D.||University of Texas Southwestern Medical Center|