Status:
UNKNOWN
Efficacy of Docosahexaenoic Acid on Tardive Dyskinesia
Lead Sponsor:
Université de Montréal
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Tardive Dyskinesia
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
Tardive dyskinesia (TD) is a well-known complication of antipsychotic drug therapy in individuals treated for mental disorders such as schizophrenia. It typically consists of purposeless, involuntary ...
Detailed Description
Background Tardive dyskinesia (TD) is a well-known complication of antipsychotic drug (APD) therapy in individuals treated for mental disorders such as schizophrenia. It typically consists of purpose...
Eligibility Criteria
Inclusion
- chronic schizophrenia 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
- 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 a history of coronary artery disease, pancreatitis, diabetes, coagulation disorders, or hemorrhagic conditions;
- those regularly taking aspirin, anticoagulants, or oral lipid-lowering agents;
- those with fasting baseline triglyceride values \>4.0 mmol/L, or with cholesterol values \>8 mmol/L ;
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00621634
Start Date
February 1 2008
Last Update
February 22 2008
Active Locations (2)
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1
Louis-H.-Lafontaine Hospital
Montreal, Quebec, Canada, H1N 3M5
2
Notre-Dame Hospital/CHU Montreal
Montreal, Quebec, Canada, H2L 4M1