Omega-3 Dietary Supplements in Schizophrenia

Completed · Not applicable · Has a placebo group

Conditions studied: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Bipolar Disorder, Psychosis NOS

In brief

This 16-week placebo-control study looks to investigate whether patients with schizophrenia for two years or less may benefit from omega-3 supplements.

Key facts

Study ID

NCT01786239

Run by

Delbert Robinson

People needed

50

Starts

2013-05-01

Expected to finish

2015-09-01

Last updated by the study team

2017-02-01

Who can join

Age: 15 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current DSM-IV-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, psychosis NOS or Bipolar I as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders;
• Does not DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder with psychotic features;
• current positive symptoms rated more than 4 (moderate) on one of these BPRS items: conceptual disorganization, grandiosity, hallucinatory behavior, and unusual thought content;
• is in a early phase of illness as defined by having taken antipsychotic medications for a cumulative lifetime period of 2 years or less;
• age 15 to 40;
• competent and willing to sign informed consent; and
• for women, negative pregnancy test and agreement to use a medically accepted birth control method.

You may not qualify if…

• serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain;
• any medical condition which requires treatment with a medication with psychotropic effects;
• significant risk of suicidal or homicidal behavior;
• cognitive or language limitations, or any other factor that would preclude subjects providing informed consent;
• medical contraindications to treatment with risperidone (e.g. neuroleptic malignant syndrome with prior risperidone exposure), omega-3 supplements (e.g. bleeding disorder, seafood allergies) or placebo capsules (e.g. allergies to capsule components);
• contraindications to MRI imaging (e.g. presence of a pacemaker);
• lack of response to a prior adequate trial of risperidone;
• taking omega-3 supplements within the past 8 weeks, and
• requires treatment with an antidepressant or mood stabilizing medication.

Where it is running

• The Zucker Hillside Hospital — Glen Oaks, New York, United States

Full record on ClinicalTrials.gov

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