Omega-3 Dietary Supplements in Schizophrenia

NCT01786239 | Completed Results DMC

• 1 other identifier: 12-308B
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Omega-3 capsules & Risperidone

EXPERIMENTAL

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.

Drug: Risperidone; Drug: Omega-3 capsules

Placebo & Risperidone

OTHER

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.

Drug: Risperidone; Drug: Placebo

Interventions

Risperidone DRUG

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.

Also known as: Risperdal

Omega-3 capsules & Risperidone; Placebo & Risperidone

Omega-3 capsules DRUG

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.

Also known as: Omega-3

Omega-3 capsules & Risperidone

Placebo DRUG

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.

Also known as: Placebo capsules

Placebo & Risperidone

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Delbert Robinson: lead
• National Institute of Mental Health (NIMH): collaborator
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

The Zucker Hillside Hospital

Glen Oaks, New York, 11040, United States

Location

Related Publications (1)

• 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.

  PMID: 30241990 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Mental Disorders

Interventions

Risperidone; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Delbert Robinson MD
• Organization: Northwell Health

drobinso@northwell.edu

7184708195

Study Officials

• Delbert G Robinson, MD

  The Zucker Hillside Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: February 7, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 1, 2017
• Results First Posted: February 1, 2017

Record last verified: 2017-01

Locations

US (1)