Omega-3 Dietary Supplements in Schizophrenia

NCT ID: NCT01786239

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-09-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Omega-3 capsules & Risperidone

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.

Group Type: EXPERIMENTAL

Risperidone

Intervention Type: DRUG

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 capsules

Intervention Type: DRUG

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.

Placebo & Risperidone

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.

Group Type: OTHER

Risperidone

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

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.

Interventions

Risperidone

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.

Intervention Type: DRUG

Omega-3 capsules

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

Risperdal; Omega-3; Placebo capsules

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role: collaborator

Delbert Robinson

OTHER

Sponsor Role: lead

Responsible Party

Delbert Robinson

Psychiatrist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Delbert G Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

The Zucker Hillside Hospital

Locations

The Zucker Hillside Hospital

Glen Oaks, New York, United States

Countries

United States

References

Robinson DG, Gallego JA, John M, Hanna LA, Zhang JP, Birnbaum ML, Greenberg J, Naraine M, Peters BD, McNamara RK, Malhotra AK, Szeszko PR. A potential role for adjunctive omega-3 polyunsaturated fatty acids for depression and anxiety symptoms in recent onset psychosis: Results from a 16 week randomized placebo-controlled trial for participants concurrently treated with risperidone. Schizophr Res. 2019 Feb;204:295-303. doi: 10.1016/j.schres.2018.09.006. Epub 2018 Sep 19.

Reference Type: DERIVED

PMID: 30241990 (View on PubMed)

Other Identifiers

12-308B

Identifier Type: -

Identifier Source: org_study_id