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

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ClinicalTrials.gov Identifier: NCT00198094
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 22, 2007
University of Pennsylvania
University of South Florida
Information provided by:
Indiana University

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.

Condition or disease Intervention/treatment Phase
Panic Disorder Drug: Sertraline and Alprazolam XR Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2003
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder
U.S. FDA Resources

Primary Outcome Measures :
  1. Panic symptoms scale score
  2. CGI-I
  3. CGI-S

Secondary Outcome Measures :
  1. Sheehan Disability Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198094

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

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

ClinicalTrials.gov Identifier: NCT00198094     History of Changes
Other Study ID Numbers: 0311-34
IU 1003
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 22, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
GABA Modulators
GABA Agents