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Citicoline for Bipolar Disorder

Phase 4
Waitlist Available
Research Sponsored by Sherwood Brown, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study month 30
Awards & highlights

Summary

This trial will test whether citicoline and pregnenolone are promising treatments for alcohol use in people with bipolar disorder.

Eligible Conditions
  • Bipolar Disorder
  • Bipolar disorder
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study month 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and study month 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Drinks per Drinking Day (TLFB)
Secondary outcome measures
Adaptive Design

Side effects data

From 2016 Phase 4 trial • 62 Patients • NCT02074735
17%
Drowsiness
14%
Dry mouth
14%
Nausea
10%
Diarrhea
7%
Headache
3%
Bruising
3%
Increased energy
3%
Hypertension
3%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Citicoline

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: PregnenoloneExperimental Treatment1 Intervention
Pregnenolone will be given beginning at 50 mg BID with an increase to 100 mg BID at week 1, 150 mg BID at week 2, and 250 mg BID at weeks 3-12.
Group II: CiticolineExperimental Treatment1 Intervention
Citicoline will be given beginning at 250 mg BID with an increase to 500 mg BID at week 1, 750 mg BID at week 2, and 1000 mg BID at weeks 3-12.
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo given beginning at 1 capsule twice daily (BID) increasing to 2 capsules BID at week 1, 3 capsules BID at week 2, and 4 capsules BID at weeks 3-12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregnenolone
2011
Completed Phase 4
~770
Citicoline
2010
Completed Phase 4
~780

Find a Location

Who is running the clinical trial?

University of Texas Rio Grande ValleyOTHER
6 Previous Clinical Trials
2,529 Total Patients Enrolled
Sherwood Brown, MD, PhDLead Sponsor
University of MiamiOTHER
918 Previous Clinical Trials
412,533 Total Patients Enrolled
4 Trials studying Bipolar Disorder
280 Patients Enrolled for Bipolar Disorder
~10 spots leftby Jul 2025