Pharmacogenomics in Autism Treatment (PG)

This study has been completed.

Sponsor:

Collaborators:

Janssen, LP

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00584701

First received: December 22, 2007

Last updated: June 18, 2012

Last verified: June 2012

History of Changes

Results First Received: September 6, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Autism
Intervention:	Drug: Risperidone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruitment at the UCDavis MIND Institute from the local community.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Active Risperidone	Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.

Participant Flow for 2 periods

Period 1: Active Risperidone

	Active Risperidone
STARTED	49
COMPLETED	46
NOT COMPLETED	3

Period 2: Follow-up

	Active Risperidone
STARTED	46
COMPLETED	34
NOT COMPLETED	12

Baseline Characteristics

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Reporting Groups

	Description
Active Risperidone	Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.

Baseline Measures

	Active Risperidone
Number of Participants [units: participants]	49
Age [units: participants]
<=18 years	49
Between 18 and 65 years	0
>=65 years	0
Age [units: years] Mean ± Standard Deviation	9.4 ± 4.3
Gender [units: participants]
Female	9
Male	40
Region of Enrollment [units: participants]
United States	49

Outcome Measures

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1. Primary:

Percent Change of ABC - Irritability Subscale Score [ Time Frame: Baseline, 8 weeks ]

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2. Secondary:

Exon Expression Positively or Negatively Correlated With Percentage Improvement in ABC-I [ Time Frame: Baseline, 8 Weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Robert Hendren, DO
Organization: UCSF
phone: 415-476-7198
e-mail: robert.hendren@ucsf.edu

No publications provided

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00584701 History of Changes
Other Study ID Numbers:	200715817-1, R21MH080026
Study First Received:	December 22, 2007
Results First Received:	September 6, 2011
Last Updated:	June 18, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

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