At a glance
ClinicalIndex Comparison Record- ✓Age 18–70 years
- ✓History of mania or hypomania (bipolar I, II, NOS, cyclothymic, or schizoaffective/bipolar type)
- ✓Early recovery from cocaine abuse/dependence: 7 days to 12 weeks of abstinence at enrollment
- ✓English or Spanish speaking
- ✕Pregnant or nursing
- ✕Prior citicoline therapy
- ✕Active suicidal or homicidal ideation with plan and intent
- ✕Dementia, intellectual disability, or severe cognitive impairment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo-controlled Trial of Citicoline add-on Therapy in Patients With a History of Mania or Hypomania and Cocaine Abuse/Dependence
In Brief
A Phase 3 clinical trial evaluating Citicoline and Placebo for Mania and 3 related conditions. Completed, enrolled 44 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
Placebo matching active medication in all other aspects.