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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
Must not have
Women who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
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.
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 belowSelect...
I understand the study's goals and can give informed consent.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
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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
219 Previous Clinical Trials
103,102 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have symptoms of tardive dyskinesia according to specific research criteria, such as muscle movements in at least two body areas or more intense movements in one body area.I regularly take aspirin, blood thinners, or cholesterol medication.I understand the study's goals and can give informed consent.Your triglyceride levels are higher than 4.0 mmol/L or your cholesterol levels are higher than 8 mmol/L when you haven't eaten for a while.You are taking supplements with omega-3 fatty acids from fish or plants.I have been on stable schizophrenia treatment for at least 3 months.You have used illegal drugs in the past year.I am not pregnant or breastfeeding.I do not have heart disease, pancreatitis, diabetes, bleeding disorders, or conditions that increase bleeding risk.I will use effective birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: 2
- Group 2: 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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