Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169949
Status:
TERMINATED
Last Update Posted:
2009-09-25
First Post:
2005-09-09
Brief Title:
Aripiprazole Treatment of the Prodrome
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-134 | None | None | None |