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Risperidone vs. Paroxetine for Panic Attacks

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ClinicalTrials.gov Identifier: NCT00206765
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : October 22, 2012
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder With Panic Attacks Panic Disorder Drug: Risperidone Drug: Paroxetine Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Single-blind Trial of Risperidone vs. Paroxetine for Treatment of Panic Attacks
Study Start Date : January 2003
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00206765     History of Changes
Other Study ID Numbers: 082-02
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012

Keywords provided by Beth Israel Medical Center:
panic

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Panic Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Anxiety Disorders
Risperidone
Paroxetine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors