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FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders (AripfMRI)

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ClinicalTrials.gov Identifier: NCT01028820
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Collaborators:
Duke University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autism Spectrum Disorder
Intervention Drug: Aripiprazole
Enrollment 13

Recruitment Details We planned to recruit participants through the NDRC Registry and Division TEACCH, as well as utilizing radio and television ads on various stations. We also posted brochures and flyers in public locations and attended conferences in order to hand out study-specific information. 13 subjects began the study and only one of those failed to complete.
Pre-assignment Details In order to participate in the research study, subjects must have been washed out from psychoactive medication for at least one month for fluoxetine, two weeks for other SSRIs and neuroleptics and five days for stimulants prior to MRI scanning, with the exception of stable doses greater than three months duration of medication for seizure disorder.
Arm/Group Title Open-Label, Flexible-Dose Aripiprazole
Hide Arm/Group Description

This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.

Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily

Period Title: Overall Study
Started 13
Completed 12
Not Completed 1
Arm/Group Title Open-Label, Flexible-Dose Aripiprazole
Hide Arm/Group Description

This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.

Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
20.31  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
1
   7.7%
Male
12
  92.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   7.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  23.1%
White
9
  69.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version
Hide Description The Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version (CY-BOCS-PDD) is a clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS—PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score > than 8 is considered clinically significant.
Time Frame Baseline ("Pre-Dose") to 8 Weeks ("Post-Dose")
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants' scores were analyzed using the PDD-CYBOCS measure. Higher values reflect worse outcomes. Subscales are added to compute the total score (total score does not include compulsion free-interval and peculiarity of the behavior.
Arm/Group Title Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose) Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)
Hide Arm/Group Description:

This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.

Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily

This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.

Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
12.7  (2.250) 8.6  (3.50)
2.Secondary Outcome
Title Total Repetitive Behavior Scale - Revised (RBS_R)
Hide Description

The RBS-R is an assessment that includes Sameness, Self-Injurious Behavior, Ritualistic, Compulsive, and Restrictive Behavior subscales. The assessments are completed by caregivers for the past week, with consideration of frequency,ease of redirecting and extent to which behavior interferes with functioning compared to a typically developing child of the same age and gender. Scores are rated from 0 - behavior does not occur to 3 - behavior occurs and is a serious problem. There are 43 items and 5 subscales. Higher scores indicate greater symptom severity. total score is the sum of all items in all subscales.

The subscales are stereotyped behaviors 6 items, self-injurious behaviors 8 items, Compulsive behaviors- 8 items, Ritualistic Behaviors 6 items, Sameness 11 items, restricted behaviors 4 items.Total score ranges from 0 to 129.

Time Frame baseline week 0, 8 weeks
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Hide Analysis Population Description
All randomized participants' scores were analyzed using the RBS-R measure. Higher values reflect worse outcomes (greater symptom severity). Subscales are added to compute the total score.
Arm/Group Title Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose) Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)
Hide Arm/Group Description:

This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.

Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily

This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.

Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
42.2  (18.37) 20.5  (13.79)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-Label, Flexible-Dose Aripiprazole
Hide Arm/Group Description

This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.

Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily

All-Cause Mortality
Open-Label, Flexible-Dose Aripiprazole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open-Label, Flexible-Dose Aripiprazole
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-Label, Flexible-Dose Aripiprazole
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia   1/13 (7.69%)  1
Ear and labyrinth disorders   
Tinnitus   1/13 (7.69%)  1
General disorders   
Body Pain   3/13 (23.08%)  3
Drowsiness   1/13 (7.69%)  1
Dry Mouth   1/13 (7.69%)  1
Fatigue   7/13 (53.85%)  7
Increased Sleep   2/13 (15.38%)  2
Nausea   1/13 (7.69%)  1
Restlessness   3/13 (23.08%)  3
Metabolism and nutrition disorders   
Increased Appetite   3/13 (23.08%)  3
Weight Gain   3/13 (23.08%)  3
Nervous system disorders   
Tremors   1/13 (7.69%)  1
Psychiatric disorders   
Depressed Mood   1/13 (7.69%)  1
Renal and urinary disorders   
Urination   1/13 (7.69%)  1
Social circumstances   
Anxiety   2/13 (15.38%)  2
Indicates events were collected by systematic assessment
The present study had 13 subjects. Due to sample size, analysis reflected an exploratory approach. If a mechanism for predicting RRB improvement is found in a study with a larger N, we could better understand therapies targeting core symptoms of ASD.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Linmarie Sikich, M.D.
Organization: The University of North Carolina at Chapel Hill
Phone: (919) 972-7499
Responsible Party: Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01028820     History of Changes
Other Study ID Numbers: 090795
K23MH081285 ( U.S. NIH Grant/Contract )
First Submitted: December 4, 2009
First Posted: December 9, 2009
Results First Submitted: November 7, 2012
Results First Posted: March 11, 2014
Last Update Posted: March 11, 2014