Overview

Omega-3 Dietary Supplements in Schizophrenia

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Delbert Robinson
Collaborators:
National Alliance for Research on Schizophrenia and Depression
National Institute of Mental Health (NIMH)
Treatments:
Risperidone
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.