Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders
|ClinicalTrials.gov Identifier: NCT00870727|
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pervasive Developmental Disorder||Drug: Aripiprazole oral product Drug: Placebo oral capsule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Pharmacotherapy of Pervasive Developmental Disorders|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||May 2015|
Experimental: Arm 1. Aripiprazole oral product
Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.
Drug: Aripiprazole oral product
Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment.
Other Name: Abilify
Placebo Comparator: Arm 2. Placebo oral capsule
Partipants will recieve matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.
Drug: Placebo oral capsule
Placebo will identical in size and appearance to study drug.
Other Name: Sugar pill
- Clinical Global Impression - Improvement [ Time Frame: At Baseline and Week 8 ]
- Aberrant Behavior Checklist Irritability Scale [ Time Frame: At Baseline and Week 8 ]
- The Aberrant Behavior Checklist Lethargy, Stereotypy, Hyperactivity and Inappropriate Speech Subscales [ Time Frame: At Baseline and Week 8 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870727
|United States, Massachusetts|
|Lexington, Massachusetts, United States, 02421|
|Principal Investigator:||Christopher J. McDougle, MD||Harvard University|