OFFICE OF CLINICAL RESEARCH
Internet Listing of a Clinical Trial
This listing REQUIRES IRB APPROVAL. It is the responsibility of the PI to obtain sponsor approval (if applicable) for the OCR study listing. Please send the completed form to Clinical Research Outreach Office (CROO) at UH 1101C or fax to 278-2895.
*DENOTES REQUIRED FIELDS
*IRB #:
*Disease/Condition: Major Depression with Psychotic features or Psychotic Depression
*Descriptive Title (lay terms): A Study of the Effectiveness and Safety off CORLUX (Mifepristone) when complared to Placebo in the treatment of Psychotic Symptoms like hallucinations or delusions that occur along with Depression.
*Enrollment Start Date: 9/15/08
Enrollment End Date: 1/15/09
*Eligibility: To qualify you must: Be between 22 and 75 years of age; have been diagnosed with Major Depression with Psychotic features, Psychotic Depression, or are experiencing symptoms and agree to be evaluated for the condition, and are generally healthy.
*Benefits: There are no direct benefits.
Additional Information (i.e. website, compensation, etc):
The study will requires a short inpatient stay of about 3 days while the study medication is started, then outpatient visits until you have completed 56 days (2 months) on the study medication. There are 14 total "visits"(days that study activities occur) paying $35.00 for each completed visit. It is possible for you to receive up to $490.00 if you complete the study.
RISKS: Risks will be disclosed prior to enrollment in a study.
*Time Commitment: 1-1 ½ hours each visit
*Location: Larue D. Carter Hospital, 2601 Cold Spring Rd, Indianapolis, Indiana
*Principal Investigator: Anantha Shekhar MD
*Contact Name: Amy Frazer
**Contact Phone: **317-941-4275**
**Contact Email: **afrazer@fssa.state.in.us
**At least one contact method is REQUIRED (phone or email)
*Keywords (for patients to search by): depression, hallucinations, psychosis
Web Address, where the clinical research study is registered: http://www.iupui.edu/~psycdept/
http://www.clinicalresearch.medicine.iu.edu, http://clinicaltrials.gov, or http://www.centerwatch.com/