Risperidone vs. Paroxetine for Panic Attacks

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Beth Israel Medical Center

ClinicalTrials.gov Identifier:

NCT00206765

First received: September 13, 2005

Last updated: October 19, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorder With Panic Attacks Panic Disorder	Drug: Risperidone Drug: Paroxetine	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

Drug Information available for: Paroxetine Paroxetine hydrochloride Risperidone Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:


Estimated Enrollment:	90
Study Start Date:	January 2003
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility


Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206765

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 Galynker, MD, PhD	Beth Israel Medical Center

More Information

No publications provided


Responsible Party:	Beth Israel Medical Center
ClinicalTrials.gov Identifier:	NCT00206765 History of Changes
Other Study ID Numbers:	082-02
Study First Received:	September 13, 2005
Last Updated:	October 19, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Beth Israel Medical Center:


panic

Additional relevant MeSH terms:


Depressive Disorder Depressive Disorder, Major Disease Mental Disorders Mood Disorders Pathologic Processes Paroxetine Risperidone Antidepressive Agents Antidepressive Agents, Second-Generation Antipsychotic Agents Central Nervous System Agents Central Nervous System Depressants	Dopamine Agents Dopamine Antagonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Antagonists Serotonin Uptake Inhibitors Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on March 01, 2015

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