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

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

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder
• Intervention / Treatment: Drug: Sertraline and Alprazolam XR

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33613
      • University of South Florida, Department of Psychiatry and Behavioral Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • University Hospital Outpatient Center, Psychiatry
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-3309
      • University of Pennsylvania, Mood and Anxiety Disorders Section

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Panic symptoms scale score
CGI-I
CGI-S

Secondary Outcome Measures

Outcome Measure
Sheehan Disability Scale

Collaborators and Investigators

• Sponsor: Indiana University School of Medicine
• Collaborators: University of Pennsylvania; University of South Florida; Pfizer
• Investigators: 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

Publications and helpful links

General Publications

• 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): 62S-62S 220 Suppl. S, APR 15 2005. IDS Number: 915VE ISSN: 0006-3223

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): October 22, 2007
• Last Update Submitted That Met QC Criteria: October 19, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Sertraline; Alprazolam
• Other Study ID Numbers: 0311-34; IU 1003