Status:
COMPLETED
A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Pfizer
University of Pennsylvania
Conditions:
Panic Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over ...
Eligibility Criteria
Inclusion
- Subjects will include men and women over the age of eighteen;
- the ability to give written informed consent;
- current principal or co-principal psychiatric diagnosis of panic disorder with or without agoraphobia based on DSM-IV criteria (American Psychiatric Association, 1994);
- willing to use an effective means of contraception;
- free of psychoactive medications for at least 2 weeks prior to study enrollment;
- not actively be suicidal.
Exclusion
- actively suicidal;
- medical conditions for which either sertraline or alprazolam XR would be contraindicated;
- recent six month history of substance or alcohol abuse;
- history or presence of psychotic or bipolar disorder;
- women who are pregnant or breastfeeding;
- history or presence of a seizure disorder or a known history of more than one childhood febrile seizure;
- presence of a personality disorder severe enough to compromise the investigator's ability to evaluate the efficacy and safety of the study medication;
- concomitant therapy with other psychotropic medication(s);
- clinically significant abnormality during physical examination, vital signs, EKG, urine drug screen, or laboratory tests at the screen visit.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00198094
Start Date
December 1 2003
End Date
September 1 2007
Last Update
October 22 2007
Active Locations (3)
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1
University of South Florida, Department of Psychiatry and Behavioral Medicine
Tampa, Florida, United States, 33613
2
University Hospital Outpatient Center, Psychiatry
Indianapolis, Indiana, United States, 46202
3
University of Pennsylvania, Mood and Anxiety Disorders Section
Philadelphia, Pennsylvania, United States, 19104-3309