Phase 3
Completed N=81
Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
Autistic Disorder
Source: ClinicalTrials.gov NCT00198107 ↗
Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase — 25.5; 18.6 units on a scale
Summary
This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase |
25.5; 18.6 | — |
| PRIMARY Odds of Improvement as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) |
0.10; 0.50 | — |
| SECONDARY Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Score, Parent Report, Double-blind Phase |
29.7; 22.5 | — |
| SECONDARY Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Score, Parent Report, Double-blind Phase |
7.4; 5.0 | — |
| SECONDARY Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Score, Parent Report, Double-blind Phase |
15.4; 11.7 | — |
| SECONDARY Mean Post-baseline Aberrant Behavior Checklist Stereotypy Score, Parent Report, Double-blind Phase |
10.0; 7.2 | — |
| SECONDARY Mean Post-baseline Score on a Modified Version of the Compulsion Subscale of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) |
14.4; 12.5 | — |
| SECONDARY Mean Vineland Maladaptive Behavior Subscales Total Score, Week 8 |
33.1; 23.1 | — |
| SECONDARY Mean Autism Diagnostic Observation Schedule (ADOS) Social Affect and Restricted and Repetitive Behaviors Total Score, Week 8 |
19.0; 18.3 | — |
| SECONDARY Mean Social Reciprocity Scale (SRS) Total Score, Week 8 |
127.6; 112.6 | — |
Eligibility Criteria
Inclusion Criteria
- Weight of at least 15 kg (33.75 lbs)
- Meets DSM-IV criteria for autistic disorder
- Outpatient
- Medication-free for at least 2 weeks prior to baseline for all psychotropic medications. More information about this criterion, including exceptions, can be found in the protocol.
- Clinical Global Impression Scale Severity score (CGI-S) of at least 4
- Irritability subscale of the Aberrant Behavior Checklist (ABC) score of at least 18
- An IQ of at least 35 or a mental age of at least 18 months
- In good physical health
Exclusion Criteria
- Meets DSM-IV criteria for Asperger's disorder, Rett's disorder, childhood disintegrative disorder, any other pervasive developmental disorder (PDD), schizophrenia, psychotic disorder, or bipolar disorder
- Current or past history of alcohol or other substance abuse within 6 months of study entry
- Comorbid neurodevelopmental disorder with possible association to autism (e.g., fragile-X syndrome, tuberous sclerosis)
- A significant medical condition such as heart, liver, kidney, or lung disease, or a seizure disorder
- Pregnant
- Prior adequate use of aripiprazole. More information about this criterion can be found in the protocol.
- Evidence of hypersensitivity to aripiprazole
- History of neuroleptic malignant syndrome
Data sourced from ClinicalTrials.gov (NCT00198107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.