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Omega-3 Dietary Supplements in Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Delbert Robinson, Northwell Health
ClinicalTrials.gov Identifier:
NCT01786239
First received: January 14, 2013
Last updated: January 30, 2017
Last verified: January 2017
  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 Disorder Psychosis NOS Drug: Risperidone Drug: Omega-3 capsules Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, 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 Delbert Robinson, Northwell Health:

Primary Outcome Measures:
  • Treatment Response [ Time Frame: 16 weeks ]
    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.


Enrollment: 50
Study Start Date: May 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (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.
Other Name: Risperdal
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.
Other Name: Omega-3
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.
Other Name: Risperdal
Drug: 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.
Other Name: Placebo capsules

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   (Child, Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786239

Locations
United States, New York
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11040
Sponsors and Collaborators
Delbert Robinson
National Institute of Mental Health (NIMH)
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Delbert G Robinson, MD The Zucker Hillside Hospital
  More Information

Responsible Party: Delbert Robinson, Psychiatrist, Northwell Health
ClinicalTrials.gov Identifier: NCT01786239     History of Changes
Other Study ID Numbers: 12-308B
Study First Received: January 14, 2013
Results First Received: September 12, 2016
Last Updated: January 30, 2017

Keywords provided by Delbert Robinson, Northwell Health:
Adolescence
Adult
Antipsychotic Agents
Female
Human
Male
Risperidone
Omega-3
Schizophrenia
Schizophreniform
Schizoaffective
Schizophrenia -- *drug therapy

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on June 27, 2017