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Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment (AEIPDT)

This study has been completed.
Sponsor:
Information provided by:
University of Buenos Aires
ClinicalTrials.gov Identifier:
NCT00803400
First received: November 7, 2008
Last updated: April 21, 2009
Last verified: April 2009
History of Changes
  Purpose

The purpose of this study is to determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than the treatment with alprazolam alone.


Condition Intervention Phase
Panic Disorder
 Drug: Alprazolam
Drug: Alprazolam + Aerobic exercise
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: a Clinical Randomized Trial

Resource links provided by NLM:

Drug Information available for: Alprazolam
U.S. FDA Resources

Further study details as provided by University of Buenos Aires:

Primary Outcome Measures:
  • Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: July 2005
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alprazolam Drug: Alprazolam

The patients assigned to the pharmacological plan will receive 4 mg alprazolam daily for 12 weeks. Two weeks after the first interview they have their first baseline psychiatric control, where all the patients are tested.

Then, at the same visit, all the patients are indicated 4 mg of alprazolam. The dose is gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12.
Active Comparator: Alprazolam + Aerobic exercise Drug: Alprazolam + Aerobic exercise

The patients assigned to exercise have to pass an ergometric test to determine the functional capacity expressed in Metabolic Equivalents of Task (METs), and their maximum heart rates to standardize the future exercise indication.

Two weeks after the first interview they have their first baseline psychiatric control and at the same time they are indicated a 4 mg dose of alprazolam, gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12.

At the same time they have to follow a protocolized aerobic exercise plan for this study 3 times a week for 12 weeks.

The type of selected exercise consists of a rapid walk (both in not inclined treadmill or natural courses) for 30 minutes divided in stages.

After each stage the patient has to control his own heart frequency that has to be maintained between 50 and 75% of their maximum not to turn to an anaerobic condition, according to the American Cardiological Association.

Detailed Description:

We have observed in our clinical practice that patients who practiced aerobic physical exercise had faster remissions and better improvement in their treatments that those who did not. There are also some scientific studies that included physical exercise in the treatment for panic disorder and compared them to other single pharmacological treatments.

So our objective will be to compare the efficacy of a pharmacological monotherapy (alprazolam), that is one of the options for the pharmacological treatment of panic disorder, with other treatment such as the combination of aerobic physical exercise and alprazolam, and to determine if this combination results in a better therapeutic response.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with panic disorder scored between 20 and 30 by the Hamilton Anxiety Rating Scale/14. (Baseline scale scores were measured during the first interview and diagnoses were made by a psychiatrist using the Structured Clinical Interview for DSM IV).
  • Good physical health and normal results determined on a previous physical examination and routine laboratory tests (renal, hepatic, hematological and thyroid function).
  • Patients who completed a written informed consent form (which was obtained from every included patient and had been fully explained before the procedure).

Exclusion Criteria:

  • A history of some kind of recent somatic disease.
  • Diagnosis of some other type of associated or psychiatric disease of axis I of DSM IV, such as affective disorders, drug dependency.
  • Hamilton Anxiety Scale lower than 20 points or higher than 30.
  • Use of some other type of medication or treatment (including psychotherapy) or having received it during last past 3 months.
  • Patients who could not complete the clinical examination
  • Patients who have not accepted to complete or sign the written informed consent.
  • Pregnant patients or in lactation. (A pregnancy test was performed for women in fertile age)
  • Patients with history of rejection to the used drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803400

Locations
Argentina
Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health
Buenos Aires, Capital Federal, Argentina, 1425
Sponsors and Collaborators
University of Buenos Aires
Investigators
Principal Investigator: Marcelo G Rudelir, MD Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Psychiatry
  More Information

Additional Information:
Psychiatry Academic Unit at Fernandez Hospital site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr.Marcelo Rudelir, Ph D, Psychiatry Academic Unit at J.A. Fernandez Hospital of Buenos Aires
ClinicalTrials.gov Identifier: NCT00803400     History of Changes
Other Study ID Numbers: UDHFMEDUBA0709
Study First Received: November 7, 2008
Results First Received: November 7, 2008
Last Updated: April 21, 2009
Health Authority: Argentina: Human Research Bioethics Committee

Keywords provided by University of Buenos Aires:
Panic disorder
Exercise
Alprazolam
Aerobic

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013