← Back to Search

Amino Acid

N-Acetylcysteine for Bipolar Disorder

Phase 2
Waitlist Available
Led By James J Prisciandarao, Ph. D
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
Meets DSM-V diagnostic criteria for Bipolar Disorder
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 5 of each experimental condition
Awards & highlights

Study Summary

This trial will study the use of two drugs to treat neurochemical imbalances in people with both bipolar disorder and alcoholism. The aim is to see if the drugs improve reaction time and alcohol cravings, as well as reduce drinking and improve mood.

Eligible Conditions
  • Bipolar Disorder
  • Alcoholism

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with Bipolar Disorder according to the DSM-V.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 5 of each experimental condition
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 5 of each experimental condition for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prefrontal GABA+ Concentrations
Prefrontal Glx Concentrations

Side effects data

From 2015 Phase 3 trial • 302 Patients • NCT01675661
7%
Headache
5%
Nausea
5%
Diarrhea
2%
Abdominal discomfort
2%
Dyspepsia
2%
Pruritis
1%
Alcohol abuse
1%
Road traffic accident
1%
Cellulitis
1%
Arthropod bite
1%
Gastrointestinal disorder
1%
Abdominal pain
1%
Vomiting
1%
Reflux disease
1%
Dizziness
1%
Insomnia
1%
Rash
1%
Energy increased
1%
Groin Abscess
1%
Flushing
1%
Fatigue
1%
Panic attack
1%
Depression
1%
Blood pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
NAC Plus CM
Placebo Plus CM

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo Oral Capsule, then N-Acetylcysteine, then GabapentinExperimental Treatment3 Interventions
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Placebo Oral Tablet: 5 day trial of matched placebo Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Group II: N-Acetylcysteine, then Placebo Oral Capsule, then GabapentinExperimental Treatment3 Interventions
3, 1 week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Placebo Oral Tablet: 5 day trial of matched placebo Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Group III: N-Acetylcysteine, then Gabapentin, then Placebo Oral CapsuleExperimental Treatment3 Interventions
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Gabapentin: 5 day trial of gabapentin with titration to 1,200mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Placebo Oral Tablet: 5 day trial of matched placebo
Group IV: Gabapentin, then Placebo Oral Capsule, then N-AcetylcysteineExperimental Treatment3 Interventions
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Gabapentin: 5 day trial of gabapentin with titration to 1,200mg Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Placebo Oral Tablet: 5 day trial of matched placebo Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Group V: Gabapentin, then N-Acetylcysteine, then Placebo Oral CapsuleExperimental Treatment3 Interventions
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Gabapentin: 5 day trial of gabapentin with titration to 1,200mg Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Placebo Oral Tablet: 5 day trial of matched placebo
Group VI: Placebo Oral Tablet, then Gabapentin, then N-AcetylcysteinePlacebo Group3 Interventions
Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Placebo Oral Tablet: 5 day trial of matched placebo Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). Gabapentin: 5 day trial of gabapentin with titration to 1,200mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7). N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-Acetylcysteine
2013
Completed Phase 3
~1470
Gabapentin
2013
Completed Phase 4
~1550
Placebo Oral Tablet
2017
Completed Phase 4
~2250

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
791 Previous Clinical Trials
1,356,930 Total Patients Enrolled
7 Trials studying Bipolar Disorder
634 Patients Enrolled for Bipolar Disorder
Medical University of South CarolinaLead Sponsor
929 Previous Clinical Trials
7,393,763 Total Patients Enrolled
9 Trials studying Bipolar Disorder
202 Patients Enrolled for Bipolar Disorder
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,628 Total Patients Enrolled
8 Trials studying Bipolar Disorder
1,191 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.

What medical applications does N-Acetylcysteine have?

"N-Acetylcysteine is commonly utilized to treat acute rhinitis and other ailments such as acetaminophen poisoning, vasomotor rhinitis, and neuralgia."

Answered by AI

Are there still available slots for participants in this research study?

"This trial, as is reflected on clinicaltrials.gov, is currently recruiting patients with a posted date of August 7th 2017 and the latest update occurring on August 1st 2022."

Answered by AI

Are there precedent studies that utilize N-Acetylcysteine?

"As of now, a total of 62 clinical trials are running to investigate the efficacy and safety of N-Acetylcysteine. 16 studies have advanced to Phase 3 while 110 different sites across Tianjin are conducting related research."

Answered by AI

How many individuals are being recruited for this medical experiment?

"Correct. According to clinicaltrials.gov, this research study is currently recruiting participants and was initially posted on August 7th 2017 with its most recent update occurring August 1st 2022. 81 patients are required from a single medical centre."

Answered by AI

Who qualifies as an eligible participant in this research endeavor?

"This medical trial is trying to recruit 81 individuals with manic disorder ranging in age from 18-65. Notably, the key inclusion criteria are serious medical issues and non-inclusionary psychiatric diseases."

Answered by AI

Does this experiment accept individuals older than thirty years of age?

"To take part in this medical experiment, one must be between 18 and 65 years of age. This trial is joined by 284 other studies recruiting those under the legal limit, as well as 873 trials for elders."

Answered by AI

Does N-Acetylcysteine pose any health risks to individuals?

"Although efficacy has yet to be substantiated, our team at Power rates N-Acetylcysteine's safety a 2 on the scale of 1 to 3 as there is prior evidence suggesting it can be utilized safely."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Medical University of South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~7 spots leftby Mar 2025