SchizophreniaNCT01786239

Omega-3 Dietary Supplements in Schizophrenia

A study testing Risperidone and Omega-3 capsules in people with Schizophrenia and Schizophreniform Disorder, run by Delbert Robinson at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 15 to 40 years
Conditions the study is for: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
What is being tested?: Risperidone and Omega-3 capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: May 2013to Sep 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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);

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Zucker Hillside Hospital
Glen Oaks, New York, 11040

Other trials in United States

About this study

Official title: Detecting Which Patients With Schizophrenia Will Improve With Omega-3 Treatment

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

Read the 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.

Conditions: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Bipolar Disorder, Psychosis NOS
Being tested: Risperidone, Omega-3 capsules, Placebo
Keywords: Adolescence, Adult, Antipsychotic Agents, Female, Human, Male, Risperidone, Omega-3, Schizophrenia, Schizophreniform, Schizoaffective, Schizophrenia -- *drug therapy
Medical subject headings: Schizophrenia, Psychotic Disorders, Bipolar Disorder, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RisperidoneDrug
Also called Risperdal
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 capsulesDrug
Also called Omega-3
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.
PlaceboDrug
Also called Placebo capsules
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.

Study groups in NCT01786239
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Risperidone; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Sep 2015

First posted7 Feb 2013 (estimated)
Study startMay 2013
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01786239
Sponsor's protocol ID: 12-308B
Status last verified: Jan 2017
First submitted: 14 Jan 2013
Last updated: 1 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 30241990

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Detecting Which Patients With Schizophrenia Will Improve With Omega-3 Treatment
ClinicalTrials.gov ID: NCT01786239
Acronym / sponsor ID: 12-308B
Conditions: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Bipolar Disorder, Psychosis NOS
Keywords: Adolescence, Adult, Antipsychotic Agents, Female, Human, Male, Risperidone, Omega-3
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Delbert RobinsonUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), National Alliance for Research on Schizophrenia and Depression
Study start: May 2013
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 7 Feb 2013 (estimated)
Results: Posted 1 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Omega-3 capsules & Risperidone	Experimental	Drug: Risperidone, Drug: Omega-3 capsulesSubjects 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.
Placebo & Risperidone	Other	Drug: Risperidone, Drug: PlaceboSubjects 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.

Who may qualify

Ages: 15 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (9 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RisperidoneAlso: RisperdalThe 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 & Risperidone, Placebo & Risperidone
Omega-3 capsulesAlso: Omega-3The 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.	Drug	Omega-3 capsules & Risperidone
PlaceboAlso: Placebo capsulesThe 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.	Drug	Placebo & Risperidone

Primary outcome

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.

Results and safety

Results posted to the registry on 1 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omega-3 Capsules & Risperidone	25	14
Amber50/50 Soybean Corn Placebo & Risperidone	25	14

Primary outcome: Treatment Response

Time frame: 16 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Omega-3 Capsules & Risperidone n = 25	Placebo & Risperidone n = 25
Baseline BPRS Score	41.64 (1.44)	42.38 (1.56)
Week 16 BPRS Score	22.5868 (2.1744)	27.2235 (2.4397)

Omega-3 Capsules & Risperidone vs Placebo & Risperidone: p = 0.0493, Mixed Models Analysis

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.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omega-3 Capsules & Risperidone	0 of 25 (0%)	0 of 25 (0%)	Not reported
Placebo & Risperidone	0 of 25 (0%)	0 of 25 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30241990Robinson 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Delbert G Robinson, MD principal investigator

The Zucker Hillside Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Risperidone and Omega-3 capsules in people with Schizophrenia and Schizophreniform Disorder, run by Delbert Robinson at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Response (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01786239, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.