Trial record 17 of 580 for:    Open Studies | "Schizophrenia"

Omega-3 Dietary Supplements in Schizophrenia

This study is currently recruiting participants.
Verified January 2014 by North Shore Long Island Jewish Health System
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Delbert Robinson, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01786239
First received: January 14, 2013
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

This 16-week placebo-control study looks to investigate whether patients with schizophrenia for two years or less may benefit from omega-3 supplements.


Condition Intervention
Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorder
Bipolar I
Drug: Risperidone
Drug: Omega-3 capsules
Drug: Amber 50/50 Soybean/Corn Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Detecting Which Patients With Schizophrenia Will Improve With Omega-3 Treatment

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Treatment Response [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The primary outcome measure will be the total Brief Psychiatric Rating Scale Score. We will also obtain baseline and end-point diffusion tensor imaging and peripheral omega-3 concentration from plasma.


Estimated Enrollment: 58
Study Start Date: May 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega-3 capsules & Risperidone
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
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.
Drug: Omega-3 capsules
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.
Amber 50/50 Soybean/Corn Placebo & Risperidone
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
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.
Drug: Amber 50/50 Soybean/Corn Placebo
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.

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

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01786239

Contacts
Contact: Jessica Greenberg, M.S. 718-470-4302 Jhandy@nshs.edu

Locations
United States, New York
The Zucker Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11040
Contact: Delbert G Robsinson, MD    718-470-8195    robinson@lij.edu   
Sponsors and Collaborators
Delbert Robinson
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Delbert G Robinson, MD The Zucker Hillside Hospital
  More Information

No publications provided

Responsible Party: Delbert Robinson, Psychiatrist, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01786239     History of Changes
Other Study ID Numbers: 12-308B
Study First Received: January 14, 2013
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by North Shore Long Island Jewish Health System:
Schizophrenia
Schizophrenia -- *drug therapy
Adolescence
Adult
Antipsychotic Agents
Female
Human
Male
Risperidone
Omega-3
Schizophreniform
Schizoaffective

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 17, 2014