Official Title: “Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: a Clinical Randomized Trial”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Alprazolam
• Active Comparator: Alprazolam + Aerobic exercise

Primary Measures

• Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No

Secondary Measures

• Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Buenos Aires

Overall Clinical Trial Officials and Contacts

Marcelo G Rudelir, MD Principal Investigator Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Psychiatry  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00803400

Study ID Number: UDHFMEDUBA0709

ClinicalTrials.gov Identifier: NCT00803400

Health Authority: Argentina: Human Research Bioethics Committee

Psychiatry Academic Unit at Fernandez Hospital site