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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
  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:


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

ClinicalTrials.gov processed this record on November 20, 2014