NCT00198094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 22, 2007

Status Verified

October 1, 2007

First QC Date

September 12, 2005

Last Update Submit

October 19, 2007

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (3)

  • Panic symptoms scale score

  • CGI-I

  • CGI-S

Secondary Outcomes (1)

  • Sheehan Disability Scale

Interventions

Sertraline and Alprazolam XRDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of South Florida, Department of Psychiatry and Behavioral Medicine

Tampa, Florida, 33613, United States

Location

University Hospital Outpatient Center, Psychiatry

Indianapolis, Indiana, 46202, United States

Location

University of Pennsylvania, Mood and Anxiety Disorders Section

Philadelphia, Pennsylvania, 19104-3309, United States

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Panic Disorder

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

December 1, 2003

Study Completion

September 1, 2007

Last Updated

October 22, 2007

Record last verified: 2007-10

Locations

US(3)