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Gabapentin for Bipolar Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bipolar Disorder+7 MoreGabapentin - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Bipolar Disorder
  • Cannabis Use Disorder
  • Cannabis Use
  • Schizoaffective Disorder, Bipolar Type
  • Cannabis Use Disorder, Severe

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Baseline to end of treatment, approximately 17 days

Day 17
Body Weight Changes

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
BXCL501
2
N-acetyl cysteine
2
N-Acetyl cysteine

Side Effects for

Gabapentin
2%Allergic reaction
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT03012815) in the Gabapentin ARM group. Side effects include: Allergic reaction with 2%.

Trial Design

3 Treatment Groups

Group A - Gabapentin
1 of 3
Group B
1 of 3
Group B - Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

68 Total Participants · 3 Treatment Groups

Primary Treatment: Gabapentin · Has Placebo Group · Phase 2

Group A - Gabapentin
Drug
Experimental Group · 1 Intervention: Gabapentin · Intervention Types: Drug
Group BPlaceboComparator Group · 1 Intervention: Group B · Intervention Types:
Group B - Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to end of treatment, approximately 17 days

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
837 Previous Clinical Trials
5,378,522 Total Patients Enrolled
9 Trials studying Bipolar Disorder
215 Patients Enrolled for Bipolar Disorder
National Institute on Drug Abuse (NIDA)NIH
2,245 Previous Clinical Trials
5,619,332 Total Patients Enrolled
14 Trials studying Bipolar Disorder
1,622 Patients Enrolled for Bipolar Disorder
James J Prisciandaro, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
23 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
New Jersey100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

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