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Study of Aripiprazole (Abilify) in Children With Symptoms of Mania

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ClinicalTrials.gov Identifier: NCT00194077
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : December 5, 2013
Last Update Posted : January 7, 2015
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert L Findling, MD, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: Aripiprazole
Drug: Placebo
Enrollment 60
Recruitment Details Recruitment University Hospitals, Case Medical Center
Pre-assignment Details Open stabilization was initiated with aripiprazole at~0.1mg/kg upon phase 1, open stabilization entry, n+96. Of these, 60 subjects met priori response to advance to phase 2.
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description Random assignment with titrated dosing Randomized assignment to placebo
Period Title: Overall Study
Started 30 30
Completed 6 [1] 0 [2]
Not Completed 24 30
Reason Not Completed
Lack of Efficacy             22             29
Study nonadherence             1             0
Withdrawal by Subject             1             1
[1]

Lack of efficacy:

Hypomania n=12 Cycling n=5 Mixed state=4 Mania n=1

[2]

Lack of efficacy:

hypomania n=17 Cycling n=6 Mania n=5 Mixed state n=1 Concern regarding tx n=1

Arm/Group Title Aripiprazole Placebo Total
Hide Arm/Group Description Abilify (Children with Symptoms of Mania Study) Placebo (Children with Symptoms of Mania Study) Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
No differences.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
30
 100.0%
30
 100.0%
60
 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%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
11
  36.7%
7
  23.3%
18
  30.0%
Male
19
  63.3%
23
  76.7%
42
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Time in Weeks to Discontinuation
Hide Description Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.
Time Frame up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description:
Aripiprazole dosing dependent upon response
Placebo dosing to mirror active treatment
Overall Number of Participants Analyzed 30 30
Mean (95% Confidence Interval)
Unit of Measure: time in weeks to discontinuation
25.93
(15.08 to 36.78)
3.00
(1.89 to 4.11)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description Abilify (Children With Symptoms of Mania Study) Placebo (Children With Symptoms of Mania Study)
All-Cause Mortality
Aripiprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Aripiprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Findling, MD,MBA Director, Child and Adolescent Psychiatry
Organization: Johns Hopkins University School of Medicine
Phone: 410-614-3225
EMail: rfindli1@jhmi.edu
Layout table for additonal information
Responsible Party: Robert L Findling, MD, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00194077     History of Changes
Other Study ID Numbers: Children with Mania
First Submitted: September 11, 2005
First Posted: September 19, 2005
Results First Submitted: June 26, 2013
Results First Posted: December 5, 2013
Last Update Posted: January 7, 2015