Fish oil for brain side effects? study pulled before start
NCT ID NCT00621634
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if high-dose DHA (an omega-3 fatty acid) could reduce involuntary movements in people with tardive dyskinesia, a side effect of long-term antipsychotic medication. It planned to enroll 40 adults aged 30-75 with schizophrenia and tardive dyskinesia, giving them DHA or placebo for 12 weeks. However, the study was withdrawn before any participants were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
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Feb 2008
An estimate. Start dates often move.
- Finished
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Feb 2010
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * patients under long-term antipsychotic drug treatment, stable for at least 3 months before study entry; * presence of tardive dyskinesia following Schooler-Kane research criteria (mild intensity (2/4 points) in at least two body segments, or moderate intensity (3∕4 points) for at least one body segment); * patients capable to understand the goals and procedures of the study, and to provide informed consent; * women of childbearing age will be requested to use an effective contraceptive method throughout the study. Exclusion Criteria: * subjects with medical conditions susceptible to significantly increase the risk of adverse effects, or to interfere with the conduct of the study; in particular, those with coronary artery disease treated with clopidogrel, coagulation disorders, or hemorrhagic conditions; * those regularly taking anticoagulants or certain triglyceride-lowering agents; * those intolerant or allergic to fish, seafood, or any other substance contained in the study medication or matching placebo; * those who have abused illegal street drugs during the past year; * those unlikely to comply with the study requirements; * those who consume natural health products of marine or vegetable source, containing omega-3 essential fatty acids; * women who are pregnant or breastfeeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3, Canada
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Notre-Dame Hospital/CHU Montreal
Montreal, Quebec, H2L 4M1, Canada
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Other studies related to the condition(s) this trial covers.
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