Omega-3 Dietary Supplements in Schizophrenia

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Delbert Robinson
• Collaborators: National Alliance for Research on Schizophrenia and Depression; National Institute of Mental Health (NIMH)
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.