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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

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests citicoline and pregnenolone in people with alcohol use disorder and bipolar or schizoaffective disorder. These treatments aim to improve brain function, reduce alcohol cravings, and stabilize mood. Citicoline modulates phospholipids metabolism and neurotransmitter levels and appears to improve cognition in some central nervous system disorders.

Eligible Conditions

Bipolar Disorder
Bipolar disorder
Alcoholism

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study month 30

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline-to-Exit Change in Drinks Per Drinking Day (TLFB)

Secondary study objectives

Examine the Use of an Adaptive Design in a Clinical Trial for Alcohol Use Disorder.

Side effects data

From 2016 Phase 4 trial • 62 Patients • NCT02074735

17%

Drowsiness

14%

Dry mouth

14%

Nausea

10%

Diarrhea

Headache

Increased energy

Bruising

Hypertension

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Citicoline

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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