Omega-3 Dietary Supplements in Schizophrenia

• Sponsor: Delbert Robinson (Other)
• Overall Status: Completed
• CT.gov ID: NCT01786239
• Collaborator: National Institute of Mental Health (NIMH) (NIH), National Alliance for Research on Schizophrenia and Depression (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder; Bipolar Disorder; Psychosis NOS	Drug: Risperidone; Drug: Omega-3 capsules; Drug: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Detecting Which Patients With Schizophrenia Will Improve With Omega-3 Treatment
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Omega-3
Other: 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 Names: 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 Names: Placebo capsules

Outcome Measures

Primary Outcome Measures

1. Treatment Response [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Delbert Robinson, Psychiatrist, Northwell Health
• ClinicalTrials.gov Identifier: NCT01786239
• Other Study ID Numbers: 12-308B
• First Posted: Feb 7, 2013
• Last Update Posted: Feb 1, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Delbert Robinson, Psychiatrist, 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; Risperidone

Study Results

Participant Flow

Arm/Group Title	Omega-3 Capsules & Risperidone	Amber50/50 Soybean Corn Placebo & Risperidone
Arm/Group 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. 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. 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.	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. 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. 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.
Period Title: Overall Study
STARTED	25	25
COMPLETED	14	14
NOT COMPLETED	11	11

Baseline Characteristics

Arm/Group Title	Omega-3 Capsules & Risperidone	Placebo & Risperidone	Total
Arm/Group 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. 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. 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.	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. 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. 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.	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	1 4%	1 2%
Between 18 and 65 years	25 100%	24 96%	49 98%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 28%	7 28%	14 28%
Male	18 72%	18 72%	36 72%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	50 100%
Structured Clinical interview for DMS-IV (SCID) (participants) [Number]
Schizophreriform	5 20%	5 20%	10 20%
Schizophrenia	17 68%	17 68%	34 68%
Bipolar 1 Disorder	2 8%	2 8%	4 8%
Psychosis NOS	0 0%	1 4%	1 2%
Schizoaffective Disorder	1 4%	0 0%	1 2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega-3 Capsules & Risperidone	Placebo & Risperidone
Arm/Group 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. 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. 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.	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. 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. 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.
Measure Participants	25	25
Baseline BPRS Score	41.64 (1.44)	42.38 (1.56)
Week 16 BPRS Score	22.5868 (2.1744)	27.2235 (2.4397)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omega-3 Capsules & Risperidone, Placebo & Risperidone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0493
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Adverse Events were assessed throughout the duration of the study. Typically these were assessed at each study visit starting at visit 1-through visits 16.Through study completion up to 16 weeks.
Arm/Group Title	Omega-3 Capsules & Risperidone		Placebo & Risperidone
Arm/Group 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. 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. 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.		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. 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. 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.
All Cause Mortality
	Omega-3 Capsules & Risperidone		Placebo & Risperidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Omega-3 Capsules & Risperidone		Placebo & Risperidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Omega-3 Capsules & Risperidone		Placebo & Risperidone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.