Clinical trial NCT01786239
Conditions: Schizophrenia Schizophreniform Disorder Schizoaffective Disorder Bipolar Disorder Psychosis NOS
Keywords: Adolescence Adult Antipsychotic Agents Female Human Male Risperidone Omega-3 Schizophrenia Schizophreniform Schizoaffective Schizophrenia -- *drug therapy
Sponsor: Delbert Robinson
Start date: 2013-05-01; Completion date: 2015-09-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Risperidone intervention 2: Omega-3 capsules intervention 3: Placebo
Intervention descriptions: intervention 1: 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 2: 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 3: 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.

Protocol documents: