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Omega-3 Dietary Supplements in Schizophrenia

Primary Purpose

Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Risperidone
Omega-3 capsules
Placebo
Sponsored by
Delbert Robinson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Adolescence, Adult, Antipsychotic Agents, Female, Human, Male, Risperidone, Omega-3, Schizophrenia, Schizophreniform, Schizoaffective, Schizophrenia -- *drug therapy

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Omega-3 capsules & Risperidone

Placebo & Risperidone

Arm Description

Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.

Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2013
Last Updated
January 30, 2017
Sponsor
Delbert Robinson
Collaborators
National Institute of Mental Health (NIMH), National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT01786239
Brief Title
Omega-3 Dietary Supplements in Schizophrenia
Official Title
Detecting Which Patients With Schizophrenia Will Improve With Omega-3 Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Delbert Robinson
Collaborators
National Institute of Mental Health (NIMH), National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 capsules & Risperidone
Arm Type
Experimental
Arm Description
Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.
Arm Title
Placebo & Risperidone
Arm Type
Other
Arm Description
Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
Intervention Type
Drug
Intervention Name(s)
Omega-3 capsules
Other Intervention Name(s)
Omega-3
Intervention Description
The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo capsules
Intervention Description
The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion.
Primary Outcome Measure Information:
Title
Treatment Response
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delbert G Robinson, MD
Organizational Affiliation
The Zucker Hillside Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11040
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30241990
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.
Results Reference
derived

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Omega-3 Dietary Supplements in Schizophrenia

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