Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00870727
• Collaborator: National Institute of Mental Health (NIMH) (NIH), Bristol-Myers Squibb (Industry)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 74.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment with individuals with Pervasive Developmental Disorder. This is a double-blind, placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be more effective than placebo for reducing aggression, tantrum and self-injurious behavior in children with Pervasive Developmental Disorder.

Condition or Disease	Intervention/Treatment	Phase
Pervasive Developmental Disorder	Drug: Aripiprazole oral product; Drug: Placebo oral capsule	Phase 3

Detailed Description

Pervasive developmental disorders (PDDs) are characterized by severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. Research suggests that a dysregulation of the dopamine and serotonin systems contributes to these interfering behaviors in individuals with PDD. After benefits of typical neuroleptics were reported in subjects with PDD, research shifted to the atypical antipsychotics which have been shown to be better tolerated and effective in this population. However, the atypical antipsychotics have also been associated with adverse effects. Thus there remains a need for a novel pharmacotherapy that would be safe and effective for children and adolescents with PDDs. The primary objectives of this study are to determine whether aripiprazole is effective and well tolerated for irritability in children and adolescents with PDD not otherwise specified (NOS) during an 8-week acute phase and whether the effectiveness and tolerability of aripiprazole is maintained during a 16-week continuation phase.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Pharmacotherapy of Pervasive Developmental Disorders
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1. Aripiprazole oral product Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.	Drug: Aripiprazole oral product; Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.; Other Names: Abilify
Placebo Comparator: Arm 2. Placebo oral capsule Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment.	Drug: Placebo oral capsule; Placebo will be identical in size and appearance to study drug.; Other Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) [Double-blind phase study exit - up to 8 weeks]

   Clinical Global Impressions (Guy, 1976) global improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7, with lower scores indicating greater improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Four participants assigned to placebo completed an exit interview prior to week 8. One participant assigned to placebo and one participant assigned to aripiprazole withdrew from the study without completing an exit interview.

2. Mean Post-baseline Aberrant Behavior Checklist Irritability Subscale Score, Parent Report, Double-blind Phase [Weeks 1, 2, 3, 4, 6 and 8]

   The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Irritability subscale is 0 to 45. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.

Secondary Outcome Measures

1. Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Subscale Score, Parent Report, Double-blind Phase [Weeks 1, 2, 3, 4, 6 and 8]

   The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers overactivity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores is 0 to 48 on the Hyperactivity subscale. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.

2. Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Subscale Score, Parent Report, Double-blind Phase [Weeks 1, 2, 3, 4, 6 and 8]

   The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Inappropriate Speech subscale is 0 to 12. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.

3. Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Subscale Score, Parent Report, Double-blind Phase [Weeks 1, 2, 3, 4, 6 and 8]

   The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Social Withdrawal subscale is 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.

4. Mean Post-baseline Aberrant Behavior Checklist Stereotypy Subscale Score, Parent Report, Double-blind Phase [Weeks 1, 2, 3, 4, 6 and 8]

   The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Stereotypy subscale is 0 to 21. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female outpatients between the ages of 5 and 17 years and greater than or equal to 15 kg body weight.

• Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revised (DSM-IV-TR) diagnosis of Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS).

• Psychotropic medication-free for at least 2 days prior to screening laboratory tests and electrocardiogram (ECG).

• Significant irritability as determined by a Clinical Global Impression Severity score of greater or equal to 4 (Moderately ill) and a score of equal to or greater than 18 on the Aberrant Behavior Checklist Irritability Subscale.

• Intelligence quotient (IQ) of equal to or greater than 50 based on the Wechsler Intelligence Scale for Children (WISC), 4th edition; the Leiter International Test of Intelligence-Revised will be used if a child is nonverbal but thought to have an IQ greater than or equal to 50.

Exclusion Criteria:

• DSM-IV-TR diagnosis other than PDD NOS (autistic disorder, Asperger's disorder, Rett's disorder, or childhood disintegrative disorder), schizophrenia, bipolar disorder or substance abuse within the last 6 months.

• Comorbid disorder with possible association to autism (e.g., Fragile X Syndrome, Tuberous Sclerosis).

• A significant medical condition such as heart, liver, renal, or pulmonary disease, or a seizure disorder, as determined by history, physical examination, or laboratory testing.

• Subjects with an active seizure disorder (history of febrile seizures in early childhood will be considered.

• Females with a positive urine pregnancy test.

• Evidence of a prior adequate trial of aripiprazole (defined as equal to or greater than 2 weeks at equal to or greater than 5 mg per day. When there is not evidence of a prior adequate trial, subjects must be medication-free for a least 2 weeks prior to baseline.

• History of neuroleptic malignant syndrome.

• Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study, including being unable to comply with the requirements of the study for any reason.

• Hypersensitivity to aripiprazole [e.g., allergic response or serious adverse effect] (significant tachycardia).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riley Hospital for Children, Christian Sarkine Autism Treatment Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University
• National Institute of Mental Health (NIMH)
• Bristol-Myers Squibb

Investigators

• Principal Investigator: Kimberly A. Stigler, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT00870727
• Other Study ID Numbers: 0805-26; MH 082119
• First Posted: Mar 27, 2009
• Last Update Posted: Jan 2, 2019
• Last Verified: Mar 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Indiana University: PDD NOS
• Additional relevant MeSH terms: Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Aripiprazole

Study Results

Participant Flow

Arm/Group Title	Arm 1. Aripiprazole Oral Product	Arm 2. Placebo Oral Capsule
Arm/Group Description	Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. Aripiprazole oral product: Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment.	Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment. Placebo oral capsule: Placebo will identical in size and appearance to study drug.
Period Title: Overall Study
STARTED	17	16
COMPLETED	16	11
NOT COMPLETED	1	5

Baseline Characteristics

Arm/Group Title	Arm 1. Aripiprazole Oral Product	Arm 2. Placebo Oral Capsule	Total
Arm/Group Description	Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. Aripiprazole oral product: Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment.	Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment. Placebo oral capsule: Placebo will identical in size and appearance to study drug.	Total of all reporting groups
Overall Participants	17	16	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.8 (3.0)	9.5 (2.3)	9.6 (2.7)
Sex: Female, Male (Count of Participants)
Female	2 11.8%	5 31.3%	7 21.2%
Male	15 88.2%	11 68.8%	26 78.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	16 94.1%	16 100%	32 97%
Unknown or Not Reported	1 5.9%	0 0%	1 3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 5.9%	3 18.8%	4 12.1%
White	15 88.2%	11 68.8%	26 78.8%
More than one race	1 5.9%	2 12.5%	3 9.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	17 100%	16 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2)
Description	Clinical Global Impressions (Guy, 1976) global improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7, with lower scores indicating greater improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Four participants assigned to placebo completed an exit interview prior to week 8. One participant assigned to placebo and one participant assigned to aripiprazole withdrew from the study without completing an exit interview.
Time Frame	Double-blind phase study exit - up to 8 weeks

Outcome Measure Data

Analysis Population Description

All randomized study participants who completed an exit interview

Arm/Group Title	Arm 1. Aripiprazole Oral Product	Arm 2. Placebo Oral Capsule
Arm/Group Description	Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.	Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment. Placebo oral capsule: Placebo will be identical in size and appearance to study drug.
Measure Participants	16	15
Number [participants]	11 64.7%	3 18.8%

2. Primary Outcome

Title	Mean Post-baseline Aberrant Behavior Checklist Irritability Subscale Score, Parent Report, Double-blind Phase
Description	The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Irritability subscale is 0 to 45. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.
Time Frame	Weeks 1, 2, 3, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

All randomized study participants

Arm/Group Title	Arm 1. Aripiprazole Oral Product	Arm 2. Placebo Oral Capsule
Arm/Group Description	Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.	Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment. Placebo oral capsule: Placebo will be identical in size and appearance to study drug.
Measure Participants	17	16
Mean (95% Confidence Interval) [units on a scale]	18.3	26.4

3. Secondary Outcome

Title	Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Subscale Score, Parent Report, Double-blind Phase
Description	The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers overactivity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores is 0 to 48 on the Hyperactivity subscale. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.
Time Frame	Weeks 1, 2, 3, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

All randomized study participants

Arm/Group Title	Arm 1. Aripiprazole Oral Product	Arm 2. Placebo Oral Capsule
Arm/Group Description	Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.	Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment. Placebo oral capsule: Placebo will be identical in size and appearance to study drug.
Measure Participants	17	16
Mean (95% Confidence Interval) [units on a scale]	23.8	29.4

4. Secondary Outcome

Title	Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Subscale Score, Parent Report, Double-blind Phase
Description	The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Inappropriate Speech subscale is 0 to 12. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.
Time Frame	Weeks 1, 2, 3, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

All randomized study participants

Arm/Group Title	Arm 1. Aripiprazole Oral Product	Arm 2. Placebo Oral Capsule
Arm/Group Description	Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.	Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment. Placebo oral capsule: Placebo will be identical in size and appearance to study drug.
Measure Participants	17	16
Mean (95% Confidence Interval) [units on a scale]	4.6	6.0

5. Secondary Outcome

Title	Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Subscale Score, Parent Report, Double-blind Phase
Description	The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Social Withdrawal subscale is 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.
Time Frame	Weeks 1, 2, 3, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

All randomized study participants

Arm/Group Title	Arm 1. Aripiprazole Oral Product	Arm 2. Placebo Oral Capsule
Arm/Group Description	Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.	Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment. Placebo oral capsule: Placebo will be identical in size and appearance to study drug.
Measure Participants	17	16
Mean (95% Confidence Interval) [units on a scale]	6.1	9.6

6. Secondary Outcome

Title	Mean Post-baseline Aberrant Behavior Checklist Stereotypy Subscale Score, Parent Report, Double-blind Phase
Description	The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Stereotypy subscale is 0 to 21. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints.
Time Frame	Weeks 1, 2, 3, 4, 6 and 8

Outcome Measure Data

Analysis Population Description

All randomized study participants

Arm/Group Title	Arm 1. Aripiprazole Oral Product	Arm 2. Placebo Oral Capsule
Arm/Group Description	Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. Aripiprazole oral product: Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.	Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment. Placebo oral capsule: Placebo will be identical in size and appearance to study drug.
Measure Participants	17	16
Mean (95% Confidence Interval) [units on a scale]	3.9	5.3

Adverse Events

Time Frame	Eight weeks or at the time of latest data collection.
Adverse Event Reporting Description	Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
Arm/Group Title	Arm 1. Aripiprazole Oral Product		Arm 2. Placebo Oral Capsule
Arm/Group Description	Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. Aripiprazole oral product: Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment.		Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment. Placebo oral capsule: Placebo will identical in size and appearance to study drug.
All Cause Mortality
	Arm 1. Aripiprazole Oral Product		Arm 2. Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)
Serious Adverse Events
	Arm 1. Aripiprazole Oral Product		Arm 2. Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1. Aripiprazole Oral Product		Arm 2. Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/17 (94.1%)		13/16 (81.3%)
Gastrointestinal disorders
Constipation	1/17 (5.9%)		0/16 (0%)
Diarrhea	1/17 (5.9%)		0/16 (0%)
Flatulence	1/17 (5.9%)		0/16 (0%)
Nausea	1/17 (5.9%)		0/16 (0%)
Stomach or abdominal discomfort	4/17 (23.5%)		3/16 (18.8%)
Vomiting	0/17 (0%)		2/16 (12.5%)
General disorders
Appetite decrease	3/17 (17.6%)		0/16 (0%)
Appetite increase	6/17 (35.3%)		2/16 (12.5%)
Dry mouth	1/17 (5.9%)		0/16 (0%)
Fever	1/17 (5.9%)		1/16 (6.3%)
Hypersalivation	4/17 (23.5%)		0/16 (0%)
Increased thirst	0/17 (0%)		1/16 (6.3%)
Other Pain	1/17 (5.9%)		0/16 (0%)
Sedation/Drowsiness	3/17 (17.6%)		1/16 (6.3%)
Tiredness/Fatigue	5/17 (29.4%)		3/16 (18.8%)
Immune system disorders
Allergies Not Otherwise Specified	0/17 (0%)		1/16 (6.3%)
Infections and infestations
Flu or upper respiratory problems	0/17 (0%)		2/16 (12.5%)
Nasal congestion or Cold	2/17 (11.8%)		6/16 (37.5%)
Sore throat	0/17 (0%)		1/16 (6.3%)
Metabolism and nutrition disorders
Weight gain	3/17 (17.6%)		1/16 (6.3%)
Weight loss	1/17 (5.9%)		0/16 (0%)
Musculoskeletal and connective tissue disorders
Muscle/bone/joint pain/condition	1/17 (5.9%)		1/16 (6.3%)
Nervous system disorders
Headache	5/17 (29.4%)		5/16 (31.3%)
Tremor	0/17 (0%)		1/16 (6.3%)
Unspecified or not otherwise listed head	1/17 (5.9%)		0/16 (0%)
Psychiatric disorders
Anxiety/Nervousness/Worry	0/17 (0%)		1/16 (6.3%)
Change in speech	1/17 (5.9%)		1/16 (6.3%)
Concentration difficulty	1/17 (5.9%)		0/16 (0%)
Daydreaming	2/17 (11.8%)		0/16 (0%)
Difficulty falling asleep	1/17 (5.9%)		3/16 (18.8%)
Echolalia	0/17 (0%)		1/16 (6.3%)
Emotional outburst	1/17 (5.9%)		0/16 (0%)
Hypertalkativeness	1/17 (5.9%)		0/16 (0%)
Increased motor activity	2/17 (11.8%)		0/16 (0%)
Interrupted sleep/other sleep problems	2/17 (11.8%)		3/16 (18.8%)
Irritability	0/17 (0%)		5/16 (31.3%)
Restlessness/Agitation including fidgety	2/17 (11.8%)		0/16 (0%)
Stereotypy	1/17 (5.9%)		0/16 (0%)
Unspecified or not otherwise listed psych	1/17 (5.9%)		0/16 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/17 (5.9%)		1/16 (6.3%)
Skin and subcutaneous tissue disorders
Generalized rash	1/17 (5.9%)		0/16 (0%)
Localized rash	1/17 (5.9%)		0/16 (0%)
Vascular disorders
Intermittent nosebleed	1/17 (5.9%)		0/16 (0%)

Limitations/Caveats

The PI who conducted the trial left the institution, Indiana University, prior to data analysis. The institution negotiated/executed a data transfer agreement for the PI's primary mentor, Dr. Christopher McDougle, to analyze the data on her behalf.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.