NCT00206765

Brief Summary

We are comparing the efficacy of Risperidone versus Paroxetine in the treatment of panic symptoms. The study hypothesis is that Risperidone will be a superior medicine for treating panic.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

Enrollment Period

2.5 years

First QC Date

September 13, 2005

Last Update Submit

October 19, 2012

Conditions

Major Depressive Disorder With Panic AttacksPanic Disorder

Keywords

panic

Interventions

RisperidoneDRUG
ParoxetineDRUG

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females, ages 21-55.
  • Ability to sign an informed consent
  • Diagnosis of Panic Disorder, or MDD with Panic attacks, single episode, recurrent, or chronic
  • HAM-A score \>17

You may not qualify if:

  • Alcohol or substance abuse within the last 6 months
  • Current diagnosis of Obsessive-Compulsive Disorder
  • Current diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Mood Disorder
  • Use of antipsychotic medications over the two months preceding enrollment in the study
  • Changes in antidepressant or mood stabilizer dosing over the two months preceding enrollment in the study
  • Previous adverse reaction to risperidone or paroxetine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

RisperidoneParoxetine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Officials

  • Igor Galynker, MD, PhD

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2003

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

October 22, 2012

Record last verified: 2012-10

Locations

US(1)