CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 81 enrolled
Drug / intervention
Aripiprazole +2 moredrug
Likely dose
Aripiprazole dosing adjusted by weight: <50 kg receives lower dose; exact dose not specified in excerpt. D-cycloserine 25-200 mg daily for final 8 weeks.AI-extracted
Key inclusion· 7
  • ✓Meets DSM-IV criteria for autistic disorder
  • ✓Weight at least 15 kg (33.75 lbs)
  • ✓IQ at least 35 or mental age at least 18 months
  • ✓Irritability score (ABC) of at least 18
Key exclusion· 9
  • ✕Meets DSM-IV criteria for Asperger's disorder, Rett's disorder, childhood disintegrative disorder, or other PDD
  • ✕Schizophrenia, psychotic disorder, or bipolar disorder
  • ✕Comorbid neurodevelopmental disorder with possible association to autism (e.g., fragile-X syndrome, tuberous sclerosis)
  • ✕Significant medical condition such as heart, liver, kidney, or lung disease, or seizure disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00198107
NCT00198107Phase 3Completed
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Novel Pharmacological Strategies in Autism

Indiana University·interventional·Posted Sep 20, 2005·Updated Apr 9, 2019

In Brief

A Phase 3 clinical trial evaluating Aripiprazole, Placebo, and 1 other intervention for Autistic Disorder. Completed, enrolled 81 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartSep 1, 2005
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 20.8 years ago

Interventions

Aripiprazoledrug

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.

Placebodrug

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

D-cycloserinedrug

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