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

University of Buenos Aires

Status and phase

Completed

Phase 4

Conditions

Panic Disorder

Treatments

Drug: Alprazolam

Drug: Alprazolam + Aerobic exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT00803400

UDHFMEDUBA0709

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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.