Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment

Phase 4

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Alprazolam	Alprazolam	Patients assigned to the pharmacological plan
Alprazolam + Aerobic exercise	Alprazolam + Aerobic exercise	Patients assigned to mix plan

Primary Outcome Measures

Name	Time	Method
Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale	12 weeks	The Hamilton Anxiety Rating Scale is a test that consists of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Each of the 14 items measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety)with a total score range of 0-56, where 17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.

Secondary Outcome Measures

Name	Time	Method
Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)	Baseline and 12 weeks	The Clinical Global Impression Severity scale is a 7 point ordinal scale that rates the severity of the patient's illness, assessing on the severity of a patient's mental illness. It ranges from 1 to 7 (1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; 7, extremely ill).
Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)	Baseline and 12 weeks	The Clinical Global Impression Improvement Scale is a 7 point ordinal scale that assesses how much the patient's illness has improved or worsened relative to a baseline state before the intervention. Rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

Locations (1): Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health
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Buenos Aires, Capital Federal, Argentina