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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00198107
First received: September 12, 2005
Last updated: April 14, 2017
Last verified: April 2017
September 12, 2005
April 14, 2017
September 2005
September 2011   (Final data collection date for primary outcome measure)
  • Aberrant Behavior Checklist (ABC) Irritability Subscale [ Time Frame: Measured at Week 8 ]
  • Clinical Global Impression (CGI) Scale [ Time Frame: Measured at Weeks 8 and 16 ]
  • - Irritability subscale of the Aberrant Behavior Checklist (ABC) after 8 weeks of Double-Blind Treatment and after Open-Label Treatment
  • - Clinical Global Impression (CGI)-global improvement item (CGI-I) after 8 weeks of Double-Blind Treatment and after Open-Label Treatment
Complete list of historical versions of study NCT00198107 on ClinicalTrials.gov Archive Site
  • ABC Subscales [ Time Frame: Measured at Weeks 8 and 16 ]
  • Vineland Maladaptive Behavior Subscales [ Time Frame: Measured at Weeks 8 and 16 ]
  • A modified version of the Compulsion Subscale of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Measured at Weeks 8 and 16 ]
  • Autism Diagnostic Observation Schedule (ADOS) [ Time Frame: Measured at Weeks 8 and 16 ]
  • Social Reciprocity Scale (SRS) [ Time Frame: Measured at Weeks 8 and 16 ]
  • - The ABC subscales other than the Irritability subscale after 8 weeks of Double-Blind Treatment and after Open-Label Treatment
  • - Vineland Maladaptive Behavior Subscales which are part of the Vineland Adaptive Behavior Scales after 8 weeks of Double-Blind Treatment and after Open-Label Treatment
  • - A Modified version of the “compulsion” subscale of the Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) after 8 weeks of Double-Blind Treatment and after Open-Label Treatment
  • - Autism Diagnostic Observation Schedule (ADOS) after 8 weeks of Double-Blind Treatment and after Open-Label Treatment
  • - Social Reciprocity Scale (SRS) after 8 weeks of Double-Blind Treatment and after Open-Label Treatment
Not Provided
Not Provided
 
Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
Novel Pharmacological Strategies in Autism
This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.

Autism is a developmental disorder that affects every child differently. A wide range of symptoms accompany autism, including self-injurious behavior, aggression, and severe tantrums. Despite an improved ability to reduce these symptoms, existing drug treatments continue to be associated with adverse side effects. Also, there is no existing drug treatment that reliably improves social behavior, a core deficit in autism. Studies on drug treatment combinations that are designed to reduce self-injurious behavior, aggression, and severe tantrums and improve social behavior in children with autism have yet to be conducted. This study will address the above-mentioned limitations by evaluating aripiprazole in reducing self-injurious behavior, aggression, and severe tantrums and by evaluating the addition of D-Cycloserine in improving social behavior among children with autism.

This study will include three phases and an add-on component for some children. Participants will be randomly assigned to receive either aripiprazole or a placebo treatment for 8 weeks. Assessments measuring irritability, behavior, and social skills will be conducted at the end of this first phase. Those patients who respond well to aripiprazole will continue to receive aripiprazole treatment for another 16 weeks. This second phase will determine whether aripiprazole is associated with long-term maintenance of symptomatic improvement in patients who respond well to short-term treatment. Assessments will again be conducted at the end of this 16-week period. Those patients whose symptoms have stabilized and continue to improve while on aripiprazole will be asked to participate in the final phase of this study. During the this pilot phase, D-Cycloserine will be added to ongoing treatment with aripiprazole. Patients will take both aripiprazole and D-Cycloserine for an additional 8 weeks to determine if this combination of drug treatments results in improved social behavior once patients' aggression and self-injurious behavior have been stabilized with aripiprazole. At the end of this 8-week period, participants will be assessed for any changes in behavior, irritability, or social skills. Results from this study may aid in developing safer and more effective drug treatments for children and adolescents with autism.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autistic Disorder
  • 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 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
    Other Name: Abilify
  • 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.
  • Placebo Comparator: 1 Placebo
    Participants will take placebo
    Intervention: Drug: Placebo
  • Active Comparator: 2 Aripiprazole
    Participants will take aripiprazole
    Intervention: Drug: Aripiprazole
  • Active Comparator: 3 Aripiprazole + D-cycloserine
    Participants first will take aripiprazole then will also take D-cycloserine
    Interventions:
    • Drug: Aripiprazole
    • Drug: D-cycloserine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00198107
R01MH072961( U.S. NIH Grant/Contract )
R01MH072961 ( U.S. NIH Grant/Contract )
DSIR 82-SEDR
Yes
Not Provided
Not Provided
Indiana University
Indiana University
National Institute of Mental Health (NIMH)
Principal Investigator: Christopher J. McDougle, MD Indiana University School of Medicine
Indiana University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP