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Trial record 86 of 408 for:    ARIPIPRAZOLE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00592683
Recruitment Status : Terminated (Supply Omega-3 Fatty Acids expired and supplier no longer made same composition.)
First Posted : January 14, 2008
Results First Posted : April 6, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Janet Wozniak, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pediatric Bipolar Disorder
Interventions Drug: Aripiprazole
Dietary Supplement: fish oil
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole + Fish Oil Aripiprazole + Placebo
Hide Arm/Group Description treatment with aripiprazole + fish oil treatment with aripiprazole + placebo
Period Title: Overall Study
Started 10 10
Completed 6 6
Not Completed 4 4
Reason Not Completed
Found ineligible             0             1
Withdrawal by Subject             1             0
Adverse Event             0             2
Protocol Violation             1             0
Study drug expired             1             0
Other             1             0
Lost to Follow-up             0             1
Arm/Group Title Aripiprazole + Fish Oil Aripiprazole + Placebo Total
Hide Arm/Group Description treatment with aripiprazole + fish oil treatment with aripiprazole + placebo Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
10
 100.0%
10
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
10.8  (3.65) 11  (3.71) 10.9  (3.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
4
  40.0%
6
  60.0%
10
  50.0%
Male
6
  60.0%
4
  40.0%
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)
Hide Description 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.
Time Frame weekly for 1st 6 weeks then biweekly
Hide Outcome Measure Data
Hide Analysis Population Description
14 subjects came in for week 12 assessments - included in final analysis.
Arm/Group Title Aripiprazole + Fish Oil Aripiprazole + Placebo
Hide Arm/Group Description:
treatment with aripiprazole + fish oil
treatment with aripiprazole + placebo
Overall Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.5  (7.78) 8.5  (7.40)
2.Secondary Outcome
Title DSM-IV Mania Symptom Checklist
Hide Description 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.
Time Frame weekly for first 6 weeks then biweekly
Hide Outcome Measure Data
Hide Analysis Population Description
14 subjects came in for week 12 assessments - included in final analysis.
Arm/Group Title Aripiprazole + Fish Oil Aripiprazole + Placebo
Hide Arm/Group Description:
treatment with aripiprazole + fish oil
treatment with aripiprazole + placebo
Overall Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.25  (5.23) 5  (3.16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole + Fish Oil Aripiprazole + Placebo
Hide Arm/Group Description treatment with aripiprazole + fish oil treatment with aripiprazole + placebo
All-Cause Mortality
Aripiprazole + Fish Oil Aripiprazole + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole + Fish Oil Aripiprazole + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole + Fish Oil Aripiprazole + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/10 (90.00%)      9/10 (90.00%)    
Ear and labyrinth disorders     
dizziness *  0/10 (0.00%)  0 1/10 (10.00%)  3
ear infection *  1/10 (10.00%)  1 0/10 (0.00%)  0
Gastrointestinal disorders     
diarrhea *  2/10 (20.00%)  4 0/10 (0.00%)  0
flatulence *  1/10 (10.00%)  2 0/10 (0.00%)  0
heartburn *  0/10 (0.00%)  0 1/10 (10.00%)  3
nausea/vomiting *  3/10 (30.00%)  4 4/10 (40.00%)  7
stomachache *  1/10 (10.00%)  1 1/10 (10.00%)  1
General disorders     
cold symptoms *  0/10 (0.00%)  0 1/10 (10.00%)  2
decreased energy *  2/10 (20.00%)  2 1/10 (10.00%)  1
decreased appetite *  0/10 (0.00%)  0 2/10 (20.00%)  3
dry mouth *  2/10 (20.00%)  3 0/10 (0.00%)  0
hand tremor *  0/10 (0.00%)  0 1/10 (10.00%)  1
headache *  0/10 (0.00%)  0 3/10 (30.00%)  5
increased appetite *  1/10 (10.00%)  2 2/10 (20.00%)  2
increased sleep *  1/10 (10.00%)  2 0/10 (0.00%)  0
irritability *  0/10 (0.00%)  0 1/10 (10.00%)  1
restless *  0/10 (0.00%)  0 1/10 (10.00%)  1
rhinorrhea *  2/10 (20.00%)  4 1/10 (10.00%)  1
sedation *  2/10 (20.00%)  3 1/10 (10.00%)  1
slurred speech *  0/10 (0.00%)  0 1/10 (10.00%)  1
sore throat *  1/10 (10.00%)  2 1/10 (10.00%)  1
sores in mouth (healed) *  0/10 (0.00%)  0 1/10 (10.00%)  1
tiredness *  7/10 (70.00%)  16 4/10 (40.00%)  7
transient facial flushing *  0/10 (0.00%)  0 1/10 (10.00%)  1
weight gain *  1/10 (10.00%)  1 0/10 (0.00%)  0
Injury, poisoning and procedural complications     
left ankle swelling (injury) *  1/10 (10.00%)  1 0/10 (0.00%)  0
sprained finger *  0/10 (0.00%)  0 1/10 (10.00%)  1
Psychiatric disorders     
saddness/crying *  0/10 (0.00%)  0 1/10 (10.00%)  1
Reproductive system and breast disorders     
period 1 week late *  0/10 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
chest pain with inspiration *  1/10 (10.00%)  1 0/10 (0.00%)  0
pneumonia *  0/10 (0.00%)  0 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders     
rash (poison ivy) *  0/10 (0.00%)  0 1/10 (10.00%)  1
skin rash *  1/10 (10.00%)  1 0/10 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Janet Wozniak, MD
Organization: Massachusetts General Hospital
Phone: 617-503-1038
EMail: jwozniak@partners.org
Layout table for additonal information
Responsible Party: Janet Wozniak, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592683     History of Changes
Other Study ID Numbers: 2007-P-000413
First Submitted: December 28, 2007
First Posted: January 14, 2008
Results First Submitted: July 15, 2011
Results First Posted: April 6, 2012
Last Update Posted: April 6, 2012