N/A
N=50
Omega-3 Dietary Supplements in Schizophrenia
Schizophrenia · Schizophreniform Disorder · Schizoaffective Disorder · Bipolar Disorder · Psychosis NOS
Bottom Line
View on ClinicalTrials.gov: NCT01786239 ↗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
| Outcome | Result | p-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.
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.