← Back to Search

Omega-3 Fatty Acid

DHA Supplements for Tardive Dyskinesia

Phase 2
Waitlist Available
Research Sponsored by Université de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients capable to understand the goals and procedures of the study, and to provide informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 14
Awards & highlights

Study Summary

This trial is testing whether DHA supplements can help reduce involuntary movements caused by tardive dyskinesia, a complication from antipsychotic drugs.

Who is the study for?
This trial is for chronic schizophrenia patients aged 30-75 with tardive dyskinesia, stable on antipsychotic drugs for at least 3 months. Participants must not use omega-3 supplements, have high blood fats or take certain medications like aspirin. Women of childbearing age should use contraception and all must consent to the study.Check my eligibility
What is being tested?
The study tests if Omega-3 fish oil capsules containing DHA can reduce involuntary movements in tardive dyskinesia patients compared to a placebo. Forty subjects will be randomly assigned to receive either DHA (3 grams daily) or a placebo for 12 weeks.See study design
What are the potential side effects?
Potential side effects may include reactions related to fish oil consumption such as bad breath, heartburn, nausea, and loose stools. Those allergic to fish could experience more severe reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I understand the study's goals and can give informed consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical rating scales (AIMS, St.Hans)
Secondary outcome measures
Erythrocyte membrane phospholipid profile (gas chromatography)
Monitoring of psychopathology (Neuro-Psychiatric Inventory, Positive and Negative Syndrome Scale, Calgary Depression Scale for Schizophrenia)
Quantitative motor testing (kinematic parameters)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Active treatment with omega-3 fish oil capsules (1 g each capsule, 50% DHA), 6 capsules each day for 12 weeks
Group II: 2Placebo Group1 Intervention
Matching placebo treatment

Find a Location

Who is running the clinical trial?

National Alliance for Research on Schizophrenia and DepressionOTHER
96 Previous Clinical Trials
4,089 Total Patients Enrolled
Université de MontréalLead Sponsor
213 Previous Clinical Trials
102,681 Total Patients Enrolled

Media Library

Docosahexaenoic Acid (DHA) (Omega-3 Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT00621634 — Phase 2
Tardive Dyskinesia Research Study Groups: 2, 1
Tardive Dyskinesia Clinical Trial 2023: Docosahexaenoic Acid (DHA) Highlights & Side Effects. Trial Name: NCT00621634 — Phase 2
Docosahexaenoic Acid (DHA) (Omega-3 Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00621634 — Phase 2

Frequently Asked Questions

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

What selection criteria are necessary to participate in this experiment?

"This medical trial is looking for 40 individuals between 30 and 75 years of age that have been diagnosed with tardive dyskinesia. Key eligibility criteria include a history of chronic schizophrenia receiving antipsychotic drugs over 3 months, presence of mild to moderate intensity Schooler-Kane research criteria in two body parts or more, capacity to understand the goals and procedures involved as well as providing informed consent; female participants must also utilize an effective contraceptive method throughout this study's duration."

Answered by AI

Is the enrollment period for this trial still open?

"The details on clinicaltrials.gov demonstrate that this trial is not currently enrolling, as the last edit was made back in February of 2008. Although recruitment has been suspended for now, 32 other trials are actively welcoming new patients at present."

Answered by AI

Is this research endeavor seeking volunteers aged 25 and over?

"Per the inclusion criteria, this clinical trial seeks patients aged 30 to 75. In addition, there are 11 trials for minors and 28 studies that cater to seniors."

Answered by AI

Is the FDA sanctioning Omega-3 fish oil capsules (including DHA) as an acceptable medication?

"The safety of Omega-3 fish oil capsules, including DHA, was ranked a 2 due to the preclinical data suggesting its security but lack of evidence indicating efficacy."

Answered by AI
Recent research and studies
~2 spots leftby Apr 2025