NCT00038896

Brief Summary

The primary objective of this study is to determine the efficacy, safety, and tolerability of a flexible dose of venlafaxine extended-release (ER) capsules administered for 10 weeks in the treatment of adult outpatients with panic disorder (PD) in a placebo-controlled phase III study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
343

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2001

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2002

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

August 14, 2009

Status Verified

August 1, 2009

Enrollment Period

1.7 years

First QC Date

June 5, 2002

Last Update Submit

August 13, 2009

Conditions

Panic Disorder

Keywords

PanicDisorder

Interventions

Venlafaxine ERDRUG

Eligibility Criteria

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

You may qualify if:

  • A male or female outpatient
  • Be at least 18 years of age and legal age of consent
  • Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1

You may not qualify if:

  • Treatment with venlafaxine (IR or ER) within 6 months of study day 1
  • Known hypersensitivity to venlafaxine (IR or ER) or related compounds
  • History or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma \[except basal cell epithelioma\], uncontrolled hypertension)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Liebowitz MR, Asnis G, Mangano R, Tzanis E. A double-blind, placebo-controlled, parallel-group, flexible-dose study of venlafaxine extended release capsules in adult outpatients with panic disorder. J Clin Psychiatry. 2009 Apr;70(4):550-61. doi: 10.4088/jcp.08m04238. Epub 2009 Apr 7.

    PMID: 19358784DERIVED

MeSH Terms

Conditions

Panic DisorderDisease

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2002

First Posted

June 7, 2002

Study Start

April 1, 2001

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

August 14, 2009

Record last verified: 2009-08