Clinical trial NCT00198094: A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients
Official title: A Randomized Double-Blind Comparison of Sertraline With Early Alprazolam XR Co-Administration vs Sertraline/Placebo for Primary Care Panic Disorder Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Panic Disorder
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: University of Pennsylvania
name: University of South Florida
First posted: 2005-09-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Panic symptoms scale score
measure: CGI-I
measure: CGI-S
Secondary outcomes:
measure: Sheehan Disability Scale
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida, Department of Psychiatry and Behavioral Medicine
state: Florida
city: Indianapolis
country: United States
facility: University Hospital Outpatient Center, Psychiatry
state: Indiana
city: Philadelphia
country: United States
facility: University of Pennsylvania, Mood and Anxiety Disorders Section
state: Pennsylvania
Study officials:
affiliation: Indiana University
name: Andrew W Goddard, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Karl Rickles, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: David Sheehan, M.D., M.B.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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