Omega-3 Dietary Supplements in Schizophrenia

Delbert Robinson50 enrolled

Overview

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

This study looks to investigate whether patients with schizophrenia for 2 years or less may benefit from omega-3 supplements. The main hypothesis to be tested in this study is that white matter integrity assessed with diffusion tensor imaging (DTI) and erythrocyte membrane omega-3 concentration may provide the means for identifying patients most likely to derive clinical benefit from omega-3 supplementation. To test this hypothesis the investigators will enroll 58 patients with recent-onset schizophrenia into a 16-week long randomized double blind placebo-controlled study of risperidone versus risperidone plus omega-3 supplementation. Study assessments after consent will include a baseline MRI and an MRI at the final visit, blood-work, clinical interviews to assess symptoms, and medical assessments for side effects. DTI exams and peripheral omega-3 concentration will be obtained prior to the initiation of treatment and the primary outcome measure will be the total Brief Psychiatric Rating Scale Score. Specific aims are: * To examine the efficacy of omega-3 fatty acids as an adjuvant agent in the treatment of patients with recent-onset schizophrenia. The investigators hypothesize that patients treated with omega-3 fatty acids will demonstrate greater Brief Psychiatric Rating Scale (BPRS) reductions compared to the placebo group. * To identify whether pre-treatment fractional anisotropy (FA) assessed by DTI predicts which patients will derive clinical benefit from omega-3 fatty acids. The investigators hypothesize that patients with lower fractional anisotropy will derive greater clinical benefit from omega-3 fatty acid supplementation. * To identify whether pre-treatment peripheral omega-3 fatty acid concentrations predict which patients will derive clinical benefit from omega-3 fatty acids. The investigators hypothesize that patients with lower peripheral omega-3 fatty acid concentrations will derive greater clinical benefit from omega-3 fatty acid supplementation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia Schizophreniform Disorder Schizoaffective Disorder Bipolar Disorder Psychosis NOS

Interventions

RisperidoneDRUG

The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.

Omega-3 capsulesDRUG

The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion.

PlaceboDRUG

The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Zucker Hillside Hospital

Glen Oaks, New York, United States

Outcomes

Primary Outcomes

Treatment Response

The primary outcome measure will be the total Brief Psychiatric Rating Scale Score. The range of the BPRS is 0 to 126 with higher scores indicated more psychological symptoms.

Time frame: 16 weeks

Data from ClinicalTrials.gov

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