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

Condition(s) targeted: Panic Disorder

Intervention: Sertraline and Alprazolam XR (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Indiana University School of Medicine

Official(s) and/or principal investigator(s):
Andrew W Goddard, M.D., Principal Investigator, Affiliation: Indiana University
Karl Rickles, M.D., Principal Investigator, Affiliation: University of Pennsylvania
David Sheehan, M.D., M.B.A., Principal Investigator, Affiliation: University of South Florida

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.

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

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

Primary outcome:

Panic symptoms scale score

CGI-I

CGI-S

Secondary outcome: Sheehan Disability Scale

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

University of South Florida, Department of Psychiatry and Behavioral Medicine, Tampa, Florida 33613, United States

University Hospital Outpatient Center, Psychiatry, Indianapolis, Indiana 46202, United States

University of Pennsylvania, Mood and Anxiety Disorders Section, Philadelphia, Pennsylvania 19104-3309, United States

Starting date: December 2003
Ending date: September 2007
Last updated: October 19, 2007