Mode
Text Size
Log in / Sign up
N/A N=50 Randomized Quadruple-blind Treatment

Omega-3 Dietary Supplements in Schizophrenia

Schizophrenia · Schizophreniform Disorder · Schizoaffective Disorder · Bipolar Disorder · Psychosis NOS

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Treatment Response — 41.64; 42.38; 22.5868; 27.2235 units on a scale — p=0.0493

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Risperidone (Drug); Omega-3 capsules (Drug); Placebo (Drug)
Age
Pediatric, Adult · 15+ yrs
Sex
All
Sponsor
Delbert Robinson
Primary completion
Sep 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Treatment Response
41.64; 42.38; 22.5868; 27.2235 0.0493 sig

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01786239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search