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

Panic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198094
• Other study ID #: 0311-34
• Secondary ID: IU 1003
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: October 19, 2007
• Start date: December 2003
• Est. completion date: September 2007

Study information

• Verified date: October 2007
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Drug:
• Sertraline and Alprazolam XR

Locations

Country	Name	City	State
United States	University Hospital Outpatient Center, Psychiatry	Indianapolis	Indiana
United States	University of Pennsylvania, Mood and Anxiety Disorders Section	Philadelphia	Pennsylvania
United States	University of South Florida, Department of Psychiatry and Behavioral Medicine	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Pfizer, University of Pennsylvania, University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (1)

A randomized double-blind comparison of sertraline with early alprazolam XR Co-administration vs. sertraline/placebo for panic disorder. Goddard AW, Ball SG, Hastings AK, Shekhar A, Rickels K, Rynn M, Janavs J, Sheehan DV. BIOLOGICAL PSYCHIATRY 57 (8): 62

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Panic symptoms scale score
Primary	CGI-I
Primary	CGI-S
Secondary	Sheehan Disability Scale