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Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents

Primary Purpose

Pediatric Bipolar Disorder

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aripiprazole

fish oil

Placebo

About this trial

This is an interventional treatment trial for Pediatric Bipolar Disorder focused on measuring bipolar disorder, fish oil, aripiprazole, children

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subject, 6-17 years of age
Subject has a DSM-IV diagnosis of bipolar I, bipolar II, or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features)
Subject and their legal representative have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol
Subject and their legal representative must be considered reliable
Subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document
Subject must have an initial score on the Young-Mania Rating Scale (Y-MRS) of at least 20
Subject must be able to participate in mandatory blood draws
Subject must be able to swallow pills
Subjects with comorbid Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Obsessive Compulsive Disorder (OCD), Pervasive Developmental Disorders (PDD), anxiety and depressive disorders will be allowed to participate in the study provided they do not meet for any of exclusionary criteria
For concomitant therapy used to treat ADHD, subject must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the ADHD therapy may not change throughout the duration of the study.

Exclusion Criteria:

Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
Serious, unstable illness including heptic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
Uncorrected hypothyroidism or hyperthyroidism
History of sensitivity to omega-3 fatty acids. A non-responder or history of intolerance to omega-3 fatty acid, after treatment at adequate doses as determined by the clinician.
Severe allergies or multiple adverse drug reactions.
Non-febrile seizures without a clear and resolved etiology
DSM-IV substance (except nicotine or caffeine) dependence within past 6 months
Judged clinically to be at serious suicidal risk
Any other concomitant medication with primarily central nervous system activity other than specified in the Concomitant Medication portion of the protocol.
Current diagnosis of schizophrenia
Pregnant or nursing females

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aripiprazole plus Fish Oil

Aripiprazole plus Placebo

Arm Description

Subjects administered aripiprazole and randomized to receive fish oil

Subjects administered aripiprazole and randomized to receive placebo

Outcomes

Primary Outcome Measures

Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)

The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60.

Secondary Outcome Measures

DSM-IV Mania Symptom Checklist

The DSM-IV Mania Symptom Checklist is used to evaluate symptoms of mania. Item scores range from 0-3, with larger scores indicating greater severity. With 33 items, the maximum (most severe) score possible is 99, with the minimum (least severe) score possible being 0.

Full Information

NCT ID

NCT00592683

First Posted

December 28, 2007

Last Updated

March 9, 2012

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00592683

Brief Title

Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents

Official Title

A Randomized Placebo Controlled Clinical Trial of Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents Ages 6-17 With Bipolar Spectrum Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Terminated

Why Stopped

Supply Omega-3 Fatty Acids expired and supplier no longer made same composition.

Study Start Date

December 2007 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as follows: Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of children and adolescents with BPD Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving active omega-3 treatment

Detailed Description

Initial clinical evidence suggests that the omega-3 fatty acids EPA (eicosapentaenoic acid) and/or DHA (docosahexaenoic acid) may play a therapeutic role in the management of mood disorders. EPA is an essential fatty acid, which can be metabolized to DHA and is a component of the human diet if fish is consumed. Aripiprazole is a novel second general antipsychotic that seems to function as a partial agonist at the dopamine D2 and serotonin 5-HT 1A receptors as well as an antagonist at the serotonin 5-HT 2A receptor. Since it has a favorable adverse event profile in adults, it is an attractive choice for the treatment of youth with bipolar disorder if proven efficacious. Although pilot research showed that omega-3 fatty acids monotherapy treatment resulted in improvement of manic symptoms, the improvement is less dramatic than that observed in trials of antipsychotics. We will test the safety and efficacy of omega-3 fatty acids versus placebo as an adjunctive treatment to open-label aripiprazole in children and adolescents with bipolar disorder. The proposed study includes 1) the use of a 12-week design to document the response rate 2) careful assessment of safety and tolerability

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric Bipolar Disorder

Keywords

bipolar disorder, fish oil, aripiprazole, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aripiprazole plus Fish Oil

Arm Type

Active Comparator

Arm Description

Subjects administered aripiprazole and randomized to receive fish oil

Arm Title

Aripiprazole plus Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects administered aripiprazole and randomized to receive placebo

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Other Intervention Name(s)

Abilify

Intervention Description

tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

fish oil

Intervention Description

1600mg (4 capsules) daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)

Description

Time Frame

weekly for 1st 6 weeks then biweekly

Secondary Outcome Measure Information:

Title

DSM-IV Mania Symptom Checklist

Description

Time Frame

weekly for first 6 weeks then biweekly

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subject, 6-17 years of age Subject has a DSM-IV diagnosis of bipolar I, bipolar II, or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) Subject and their legal representative have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol Subject and their legal representative must be considered reliable Subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document Subject must have an initial score on the Young-Mania Rating Scale (Y-MRS) of at least 20 Subject must be able to participate in mandatory blood draws Subject must be able to swallow pills Subjects with comorbid Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Obsessive Compulsive Disorder (OCD), Pervasive Developmental Disorders (PDD), anxiety and depressive disorders will be allowed to participate in the study provided they do not meet for any of exclusionary criteria For concomitant therapy used to treat ADHD, subject must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the ADHD therapy may not change throughout the duration of the study. Exclusion Criteria: Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild Serious, unstable illness including heptic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease Uncorrected hypothyroidism or hyperthyroidism History of sensitivity to omega-3 fatty acids. A non-responder or history of intolerance to omega-3 fatty acid, after treatment at adequate doses as determined by the clinician. Severe allergies or multiple adverse drug reactions. Non-febrile seizures without a clear and resolved etiology DSM-IV substance (except nicotine or caffeine) dependence within past 6 months Judged clinically to be at serious suicidal risk Any other concomitant medication with primarily central nervous system activity other than specified in the Concomitant Medication portion of the protocol. Current diagnosis of schizophrenia Pregnant or nursing females

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janet Wozniak, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02138

Country

United States

12. IPD Sharing Statement

Links:

URL

http://massgeneral.org/pediatricpsych/home.html

Description

Related Info

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Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents

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