Schizophrenia Clinical Trial
Official title:
Detecting Which Patients With Schizophrenia Will Improve With Omega-3 Treatment
Verified date | January 2017 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This 16-week placebo-control study looks to investigate whether patients with schizophrenia for two years or less may benefit from omega-3 supplements.
Status | Completed |
Enrollment | 50 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | The Zucker Hillside Hospital | Glen Oaks | New York |
Lead Sponsor | Collaborator |
---|---|
Delbert Robinson | National Alliance for Research on Schizophrenia and Depression, National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment Response | The primary outcome measure will be the total Brief Psychiatric Rating Scale Score. The range of the BPRS is 0 to 126 with higher scores indicated more psychological symptoms. | 16 weeks |
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