NCT00457106

Brief Summary

This study compares the efficacy of risperidone to that of paroxetine in the treatment of panic attacks in patients with Panic Disorder and with Major Depressive Disorder with Panic attacks and compares the side effect profile of risperidone vs. paroxetine in treatment of panic attacks and compares response rates of risperidone vs. paroxetine in treatment of panic attacks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

1 active site

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

June 1, 2002

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
Last Updated

December 1, 2010

Status Verified

November 1, 2010

Enrollment Period

1 year

First QC Date

April 3, 2007

Last Update Submit

November 30, 2010

Conditions

Major Depression With Panic AttacksPanic Disorder

Keywords

panic

Outcome Measures

Primary Outcomes (1)

  • Hamilton Anxiety Rating Scale

Secondary Outcomes (4)

  • Hamilton Depression Rating Scale

  • Panic Disorder Severity Scale

  • Sheehan Panic and Anxiety Scale - Patient rated

  • Clinical Global Impressions Scale

Interventions

ParoxetineDRUG
RisperidoneDRUG

Eligibility Criteria

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

You may qualify if:

  • Males and females, ages 18-55.
  • 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

Related Publications (1)

  • Prosser JM, Yard S, Steele A, Cohen LJ, Galynker II. A comparison of low-dose risperidone to paroxetine in the treatment of panic attacks: a randomized, single-blind study. BMC Psychiatry. 2009 May 26;9:25. doi: 10.1186/1471-244X-9-25.

    PMID: 19470174DERIVED

MeSH Terms

Conditions

Panic Disorder

Interventions

ParoxetineRisperidone

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinonesPyrimidines

Study Officials

  • Igor I Galynker, M.D., Ph.D.

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 5, 2007

Study Start

June 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

December 1, 2010

Record last verified: 2010-11

Locations

US(1)