Omega-3 Dietary Supplements in Schizophrenia
Condition: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder; Bipolar Disorder; Psychosis NOS
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Study type: Interventional

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.
    

Intervention name(s): Risperidone; Omega-3 capsules; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): Risperdal; Omega-3; Placebo capsules
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescence; Adult; Antipsychotic Agents; Female; Human; Male; Risperidone; Omega-3; Schizophrenia; Schizophreniform; Schizoaffective; Schizophrenia -- *drug therapy