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

NCT00198094

Last updated date
Study Location
University of South Florida, Department of Psychiatry and Behavioral Medicine
Tampa, Florida, 33613, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Panic Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
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