A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
This study has been completed.
Sponsor:
Indiana University School of Medicine
Collaborators:
Pfizer
University of Pennsylvania
University of South Florida
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00198094
First received: September 12, 2005
Last updated: October 19, 2007
Last verified: October 2007
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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 4 |
| 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:
Further study details as provided by Indiana University:
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 May 23, 2013