Omega-3 Dietary Supplements in Schizophrenia

Delbert Robinson

Status: Completed

Conditions: Schizophreniform Disorder; Schizophrenia; Bipolar Disorder; Schizoaffective Disorder; Psychosis NOS

Treatments: Drug: Omega-3 capsules; Drug: Placebo; Drug: Risperidone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01786239

12-308B

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Omega-3 capsules & Risperidone

Experimental group

Description:

Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.

Treatment:

Drug: Risperidone

Drug: Omega-3 capsules

Placebo & Risperidone

Other group

Description:

Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.

Treatment:

Drug: Risperidone

Drug: Placebo