NCT00195598

Brief Summary

The purpose of this pilot study is to evaluate the improvement in social function following therapy with venlafaxine extended release (XR) in the treatment of panic disorder (PD) in comparison to paroxetine. An additional purpose of this pilot study is to obtain the tolerability of using venlafaxine extended release (XR) in the treatment of panic disorder (PD) in comparison to paroxetine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

April 2, 2010

Status Verified

March 1, 2010

Enrollment Period

1.2 years

First QC Date

September 12, 2005

Last Update Submit

April 1, 2010

Conditions

Panic Disorders

Keywords

Panic Disorders

Outcome Measures

Primary Outcomes (1)

  • To evaluate the improvement of social function following therapy with Venlafaxine extended release (XR)in the Treatment of Panic Disorder in comparison to Paroxetine.

Secondary Outcomes (1)

  • Obtain the tolerability of using Venlafaxine extended release (XR) in the treatment of Panic Disorder in comparison to Paroxetine.

Interventions

VENLAFAXINEDRUG
ParoxetineDRUG

Eligibility Criteria

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

You may qualify if:

  • Meet DSM IV criteria for Panic Disorder (with or without agoraphobia) for at least 3 months before study day 1.
  • Have a minimum of 8 full-symptom panic attacks during the 4 weeks before the screening visit.
  • Provide a written informed consent

You may not qualify if:

  • Treatment with Venlafaxine within 6 months of study day 1, as well Paroxetine
  • Known hypersensitivity to Venlafaxine or related compounds as well to Paroxetine.
  • Psychopharmacologic drugs within 14 days of study day 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Jundiaí, São Paulo, Brazil

Location

Unknown Facility

Santo André, São Paulo, 09290-610, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04038-031, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04829-000, Brazil

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Venlafaxine HydrochlorideParoxetine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Trial Manager

    Pfizer CT.gov Call Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

January 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

April 2, 2010

Record last verified: 2010-03

Locations

BR(4)