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Gamma-Aminobutyric Acid (GABA) Analog

Gabapentin for Bipolar Disorder

Phase 2
Recruiting
Led By James J Prisciandaro, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)
Ages 18-65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of treatment, approximately 17 days
Awards & highlights

Study Summary

This trial will study the effects of Gabapentin on people with Bipolar Disorder who use marijuana. They will take the medication or a placebo for 17 days, and have 5 study visits with 2 MRI brain scans.

Who is the study for?
Adults aged 18-65 with bipolar disorder and moderate to severe cannabis use disorder, who are already on mood stabilizers, can join this study. They must be willing to take medication and attend follow-ups. Exclusions include certain medical conditions, recent electroconvulsive therapy, pregnancy or inadequate contraception use, high risk of suicide or homicide, past negative reactions to gabapentin or MRI scans.Check my eligibility
What is being tested?
The trial is testing Gabapentin against a placebo in people with bipolar disorder who also smoke marijuana. Over 17 days, participants will take the assigned treatment and undergo brain scans (MRI), questionnaires, interviews, and side effect monitoring during five visits.See study design
What are the potential side effects?
Potential side effects from Gabapentin may include dizziness, sleepiness, water retention leading to swelling in limbs, difficulty walking normally; however specific side effects for this trial will be consistently assessed at each visit.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I take a daily mood stabilizer like lithium or lamotrigine.
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I am between 18 and 65 years old.
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I have a significant problem with cannabis use, tested positive for it, and it's my main substance issue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of treatment, approximately 17 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of treatment, approximately 17 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A - GabapentinExperimental Treatment1 Intervention
Group II: Group B - PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
2013
Completed Phase 4
~1550

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
931 Previous Clinical Trials
7,393,943 Total Patients Enrolled
9 Trials studying Bipolar Disorder
188 Patients Enrolled for Bipolar Disorder
National Institute on Drug Abuse (NIDA)NIH
2,455 Previous Clinical Trials
2,596,896 Total Patients Enrolled
15 Trials studying Bipolar Disorder
1,712 Patients Enrolled for Bipolar Disorder
James J Prisciandaro, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

Gabapentin (Gamma-Aminobutyric Acid (GABA) Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05064319 — Phase 2
Bipolar Disorder Research Study Groups: Group A - Gabapentin, Group B - Placebo
Bipolar Disorder Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT05064319 — Phase 2
Gabapentin (Gamma-Aminobutyric Acid (GABA) Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05064319 — Phase 2

Frequently Asked Questions

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

How widespread is the participation in this research project?

"Affirmative. The information posted on clinicaltrials.gov reveals that this medical trial, which was initially published on February 24th 2022 is currently seeking volunteers. Approximately 68 participants need to be enlisted from a single site."

Answered by AI

Is this medical experiment open to elderly individuals?

"This research trial adheres to strict age requirements, demanding that potential participants must be 18 or above and 65 or below."

Answered by AI

Are there any other research initiatives that have studied the effects of Gabapentin?

"Currently, 25 studies are underway for the evaluation of Gabapentin's efficacy with 9 trials in their final phase. These clinical research sites span 67 different locations across the country but many have chosen to conduct their study in Columbus, Ohio."

Answered by AI

To what type of ailments does Gabapentin offer symptomatic relief?

"Gabapentin can be leveraged to alleviate the symptoms of neuralgia, epilepsies and postherpetic neuralgia."

Answered by AI

Is registration for this experiment still open to participants?

"Affirmative. Clinicaltrials.gov stipulates that this trial, which was initially posted on February 24th 2022, is actively enrolling participants in need of treatment. 68 volunteers are needed from 1 medical institution."

Answered by AI

What risks come with taking Gabapentin on a regular basis?

"Based on available evidence, Gabapentin has been estimated to have a safety score of 2. This is due to its Phase 2 status, indicating that there are reports supporting the drug's safety yet no backing for efficacy."

Answered by AI

Am I eligible to sign up for participation in this research?

"The requirements for admission to this trial are a manic disorder diagnosis and an age between 18 and 65. Space is limited, with only 68 spots available in total."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~35 spots leftby Jun 2026