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Trial record 1 of 1 for:    NCT00198094
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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
Sponsor:
Collaborators:
Pfizer
University of Pennsylvania
University of South Florida
Information provided by:
Indiana University

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date October 22, 2007
Study Start Date  ICMJE December 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Panic symptoms scale score
  • CGI-I
  • CGI-S
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Sheehan Disability Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
Official Title  ICMJE A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs Sertraline/Placebo for Primary Care Panic Disorder Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Panic Disorder
Intervention  ICMJE Drug: Sertraline and Alprazolam XR
Study Arms  ICMJE Not Provided
Publications * 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 12, 2005)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00198094
Other Study ID Numbers  ICMJE 0311-34
IU 1003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Indiana University School of Medicine
Collaborators  ICMJE
  • Pfizer
  • University of Pennsylvania
  • University of South Florida
Investigators  ICMJE
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
PRS Account Indiana University
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP