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

This study has been completed.

First Received on September 12, 2005. Last Updated on October 19, 2007 History of Changes

Sponsor:	Indiana University School of Medicine
Collaborators:	Pfizer University of Pennsylvania University of South Florida
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00198094

Purpose

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	Intervention	Phase
Panic Disorder	Drug: Sertraline and Alprazolam XR	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Panic Disorder

Drug Information available for: Alprazolam Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

Panic symptoms scale score
CGI-I
CGI-S

Secondary Outcome Measures:

Sheehan Disability Scale

Estimated Enrollment:	150
Study Start Date:	December 2003
Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198094

Locations

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

Pfizer

University of Pennsylvania

University of South Florida

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00198094 History of Changes
Other Study ID Numbers:	0311-34, IU 1003
Study First Received:	September 12, 2005
Last Updated:	October 19, 2007
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Panic Disorder
Anxiety Disorders
Mental Disorders
Alprazolam
Sertraline
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 12, 2012