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

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 Overview

• Status: Completed
• Conditions: Panic Disorder
• Intervention / Treatment: Drug: Alprazolam; Drug: Alprazolam + Aerobic exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Capital Federal
    • Buenos Aires, Capital Federal, Argentina, 1425
      • Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alprazolam; Patients assigned to the pharmacological plan	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.; Other Names: Non exercise group
Active Comparator: Alprazolam + Aerobic exercise; Patients assigned to mix plan	Drug: Alprazolam + Aerobic exercise; The patients assigned to exercise have to pass an ergometric test to determine their functional capacity expressed in METs for 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. Then they follow a protocolized aerobic exercise plan for this study during 12 weeks. The type of selected exercise consists of a rapid walk for 30 minutes divided in stages. After each stage the patient has to control his own heart frequency that has to be between 50 and 75% of their maximum to assure an aerobic condition (American Cardiological Association).; Other Names: Exercise group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)	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).	Baseline and 12 weeks
Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)	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.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of Buenos Aires
• Investigators: Principal Investigator: Marcelo G Rudelir, MD, Psychiatry and Mental Health Department at University of Buenos Aires

Publications and helpful links

General Publications

• Toro Martinez E, Rudelir M. [Assessment of suicide risk: clinical and legal aspects]. Vertex. 2005 May-Jun;16(61):196-205. Spanish.

Helpful Links

• Psychiatry and Mental Health Department at University of Buenos Aires

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): September 30, 2009

Study Registration Dates

• First Submitted: November 7, 2008
• First Submitted That Met QC Criteria: December 3, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: July 24, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Panic disorder; Alprazolam; Aerobic
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Anxiety Disorders; Disease; Panic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Alprazolam
• Other Study ID Numbers: UDHFMEDUBA0709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes