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Completed

NCT Number: NCT00198094

A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in 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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of South Florida, Department of Psychiatry and Behavioral Medicine, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sertraline and Alprazolam XR

Drug

Primary outcomes

  1. Panic symptoms scale score

  2. CGI-I

  3. CGI-S

Secondary outcomes

  1. Sheehan Disability Scale

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Pfizer
  • University of Pennsylvania
  • University of South Florida

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Oct 22, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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