Clinical trial NCT01786239: Omega-3 Dietary Supplements in Schizophrenia
Official title: Detecting Which Patients With Schizophrenia Will Improve With Omega-3 Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorder
Bipolar Disorder
Psychosis NOS
Keywords: Adolescence
Adult
Antipsychotic Agents
Female
Human
Male
Risperidone
Omega-3
Schizophrenia
Schizophreniform
Schizoaffective
Schizophrenia -- *drug therapy
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Alliance for Research on Schizophrenia and Depression
First posted: 2013-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Treatment Response
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
Study officials:
affiliation: The Zucker Hillside Hospital
name: Delbert G Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson DG, Gallego JA, John M, Hanna LA, Zhang JP, Birnbaum ML, Greenberg J, Naraine M, Peters BD, McNamara RK, Malhotra AK, Szeszko PR. A potential role for adjunctive omega-3 polyunsaturated fatty acids for depression and anxiety symptoms in recent onset psychosis: Results from a 16 week randomized placebo-controlled trial for participants concurrently treated with risperidone. Schizophr Res. 2019 Feb;204:295-303. doi: 10.1016/j.schres.2018.09.006. Epub 2018 Sep 19.