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

Study Overview
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Brief Summary
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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.

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

Conditions
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Panic Disorder

Intervention / Treatment
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* Drug: Sertraline and Alprazolam XR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sertraline and Alprazolam XR|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Panic symptoms scale score |  |  | 
| CGI-I |  |  | 
| CGI-S |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sheehan Disability Scale |  |  |