← Back to Search

Other

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 12 weeks
Awards & highlights

Study Summary

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

Eligible Conditions
  • Bipolar Disorder
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Timeline Followback (TLFB)

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
Citicoline
Placebo

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 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
899 Previous Clinical Trials
409,636 Total Patients Enrolled
4 Trials studying Bipolar Disorder
280 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be suitable to join this medical experiment?

"Those that wish to join this clinical trial must have manic disorder, and be aged 18-70 years old. The total enrolment goal is 199 participants."

Answered by AI

Is the stipulated age range for this experiment inclusive of individuals over 55 years old?

"According to the trial parameters, individuals aged between 18 and 70 are eligible for enrolment."

Answered by AI

What potential perils are associated with Citicoline consumption?

"The safety of Citicoline was rated a 3 due to the drug's Phase 4 status, indicating it has been sanctioned for use."

Answered by AI

Would this experiment currently accept volunteers?

"Clinicaltrials.gov displays that this ongoing medical study is actively welcoming participants, first posted on May 1st 2016 and most recently updated July 11th 2022."

Answered by AI

What is the approximate sample size for this clinical experiment?

"Affirmative. Clinicaltrials.gov's records divulge that this research endeavor, which was first published on May 1st 2016, is actively in search of volunteers. Approximately 199 participants need to be sourced from a single clinic site."

Answered by AI

Could you elucidate other investigations that have been done on Citicoline?

"Currently, 16 investigations into the efficacy of Citicoline are underway with four trials in their third and final phase. Minneapolis is a major location for this research, but 17 other sites across the US have also been enlisted to conduct studies on Citicoline."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Clinical Medication Development for Bipolar Disorder and Alcohol Use Disorders
Sherwood Brown, MD, PhD 2016. "Clinical Medication Development for Bipolar Disorder and Alcohol Use Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02582905.
~11 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top