A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 19, 2007

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Panic symptoms scale score
CGI-I
CGI-S

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00198094 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sheehan Disability Scale

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients

Official Title ^ICMJE

A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs Sertraline/Placebo for Primary Care Panic Disorder Patients

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 a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Panic Disorder

Intervention ^ICMJE

Drug: Sertraline and Alprazolam XR

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

150

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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 Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00198094

Responsible Party

Study ID Numbers ^ICMJE

0311-34, IU 1003

Study Sponsor ^ICMJE

Indiana University School of Medicine

Collaborators ^ICMJE

Pfizer
University of Pennsylvania
University of South Florida

Investigators ^ICMJE

Principal Investigator:	Andrew W Goddard, M.D.	Indiana University
Principal Investigator:	Karl Rickles, M.D.	University of Pennsylvania
Principal Investigator:	David Sheehan, M.D., M.B.A.	University of South Florida

Information Provided By

Indiana University

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP