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

NCT ID: NCT00198094

Last Updated: 2007-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2007-09-30

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.

Conditions

Panic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Sertraline and Alprazolam XR

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: collaborator

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Principal Investigators

Andrew W Goddard, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Karl Rickles, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

David Sheehan, M.D., M.B.A.

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida, Department of Psychiatry and Behavioral Medicine

Tampa, Florida, United States

University Hospital Outpatient Center, Psychiatry

Indianapolis, Indiana, United States

University of Pennsylvania, Mood and Anxiety Disorders Section

Philadelphia, Pennsylvania, United States

Countries

United States

References

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

Reference Type: RESULT

Other Identifiers

IU 1003

Identifier Type: -

Identifier Source: secondary_id

0311-34

Identifier Type: -

Identifier Source: org_study_id