Aripiprazole Treatment of the Prodrome | NCT00169949

Studies
Aripiprazole Treatment of the Prodrome

NCT00169949

Sponsor

Northwell Health

Status

Terminated

Last Update Posted

Sep 25, 2009Estimated

Enrollment

Phase

Not Applicable

Conditions

Prodromal Schizophrenia
Prodromal Psychosis

Interventions

aripiprazole

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
03-134

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated due to low enrollment.

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

May 2006Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2009

Last Update Posted Date

Sep 25, 2009Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The RAP Program is conducting a research study of the antipsychotic medication Aripiprazole. This drug has been approved for treating symptoms associated with schizophrenia and is associated with fewer side effects. This study will explore how well Aripiprazole treats symptoms of early-onset psychotic disorders as well as symptoms that may indicate risk for such disorders, including unusual thoughts, suspiciousness, perceptual abnormalities, social isolation, and sudden changes in functioning.

Detailed Description

During the 12-week study, eligible patients are seen 7-9 times by research raters and psychiatrists. These visits include side effect monitoring, scheduled medication increases, and ratings designed to measure subtle improvement of symptoms. Monthly blood and urine samples are collected for safety and substance abuse monitoring, and neuropsychological testing is conducted at the first and last appointments. Participants are compensated for their participation and receive medication and study-related visits at no cost during the trial. Depending on their level of response to the medication, participants may also be eligible for a 3-month extension phase.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
aripiprazole	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score on attenuated positive symptom scale at 12 weeks
Score on attenuated negative symptom scale at 12 weeks
Score on adverse events rating scale at 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Score on social functioning scale at 12 weeks
Score on academic functioning scale at 12 weeks
Score on cognitive measures at 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

You are between the ages of 13 and 22.
You are English-speaking.
You have a diagnosed psychotic disorder, including: schizophrenia, schizophreniform disorder, schizoaffective disorder, or other psychotic disorder
OR -
You are experiencing one or more pre-psychotic symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
You meet additional RAP criteria assessed during screening and interview.

Exclusion Criteria:

You have a diagnosis of bipolar disorder or major depression with psychotic features.
You have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
You have past or current substance dependence.
You are currently taking Aripiprazole.
You have taken Aripiprazole in the past.
You are currently taking and responding well to another medication.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

22 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara Cornblatt, PhD	LIJMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital		Glen Oaks	New York	11004	United States

Condition Browse Module

MeSH Terms

ID	Term
D012569	Schizotypal Personality Disorder
D012917	Social Adjustment

Ancestor Terms

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders
D012919	Social Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068180	Aripiprazole

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones

Browse Leaves

Not provided

Browse Branches

Not provided