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Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism

NCT00198107 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-04-09

Study results available
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Summary

This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.

Conditions

  • Autistic Disorder

Interventions

DRUG

Aripiprazole

Participants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 kg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.

DRUG

Placebo

Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.

DRUG

D-cycloserine

D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Christopher J. McDougle, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00198107 on ClinicalTrials.gov