Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|