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A Single-Blind Trial of Risperidone vs. Paroxetine for Treatment of Panic Attacks

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00457106
First received: April 3, 2007
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Major Depression With Panic Attacks
Panic Disorder
 Drug: Paroxetine
Drug: Risperidone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Single-Blind Trial of Risperidone vs. Paroxetine for Treatment of Panic Attacks

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Hamilton Anxiety Rating Scale

Secondary Outcome Measures:
  • Hamilton Depression Rating Scale
  • Panic Disorder Severity Scale
  • Sheehan Panic and Anxiety Scale - Patient rated
  • Clinical Global Impressions Scale

Estimated Enrollment: 90
Study Start Date: June 2002
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457106

Locations
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Igor I Galynker, M.D., Ph.D. Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Igor Galynker, Beth Israel medical Center
ClinicalTrials.gov Identifier: NCT00457106     History of Changes
Other Study ID Numbers: IRB#: 082-02
Study First Received: April 3, 2007
Last Updated: November 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
panic

Additional relevant MeSH terms:
Depression
Depressive Disorder
Panic Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders
Paroxetine
Risperidone
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Serotonin Antagonists
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013