A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
NCT00198094
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Adult Trials: 18+ Years
- 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.
- 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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| 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 | 150 | |||||||||
| Original Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date ICMJE | September 2007 | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| Investigators ICMJE |
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| 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 | ||||||||||