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NCT00619723 · ClinicalTrials.gov registry record · Phase 4
Citicoline for Bipolar 1 Disorder and Cocaine Dependence
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 130
- Enrollment target
NCT00619723 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 130 participants.
The verdict
NCT00619723, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 130 participants
- Enrollment target
Study Summary
A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial of citicoline as an add-on therapy will be conducted in 200 outpatients with bipolar I disorder and cocaine dependence. Patients will complete mood and memory assessments weekly, in addition to completing self-report measures for cocaine (and other substances, like alcohol) use and craving. Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT. The sessions may be videotaped for training purposes and may be viewed by the researchers, the therapist, and Dr. Schmitz, a clinical researcher at the University of Texas Houston who is the developer of the CBT for bipolar disorder and substance dependence used in the study. Before being videotaped, the patient will sign an "Authorization for Audio Recordings, Photography, or Other Images for Non-Treatment Purposes" to further understand how the videotape will be used, and by whom. The patient will be given the option to review their videotape to view their therapy session. Once the patient has completed all study procedures, or had discontinued the study, the tape will be destroyed, until then the tape will kept in the patient's confidential study file. Further, patients will return to the clinic three times a week for urine drug tests (UDS). 200 patients are expected to be consented for this study and all study procedures will take place at the clinic on the University of Texas Southwestern Medical Center campus. All non-study medications are not part of the study. Non-study medication will be verbally self-reported by the patient at the time of enrollment into the study. The patient will be responsible for the costs of their non-study related medications. The patient will manage their non-study medications with the
Interventions
- DRUG Placebo
- BEHAVIORAL Cognitive Behavioral Therapy (CBT)
- DRUG Citicoline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2008-04 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00619723
The ClinicalTrials.gov registry entry for NCT00619723 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00619723 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00619723 about?
NCT00619723 is a clinical study titled "Citicoline for Bipolar 1 Disorder and Cocaine Dependence". A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial of citicoline as an add-on therapy will be conducted in 200 outpatients with bipolar I disorder and cocaine dependence. Patients will complete mood and memory assessments weekly, in addition to completing self-report measu...
What is the current status of trial NCT00619723?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 130 participants. The study started on 2008-04. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00619723?
The interventions under investigation include: Placebo (DRUG), Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Citicoline (DRUG).
Who is sponsoring clinical trial NCT00619723?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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