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

Primary Purpose

Panic Disorder

Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Alprazolam
Alprazolam + Aerobic exercise
Sponsored by
University of Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Panic disorder, Exercise, Alprazolam, Aerobic

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Alprazolam

Alprazolam + Aerobic exercise

Arm Description

Patients assigned to the pharmacological plan

Patients assigned to mix plan

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
November 7, 2008
Last Updated
July 24, 2021
Sponsor
University of Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT00803400
Brief Title
Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment
Acronym
AEIPDT
Official Title
Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: a Clinical Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2008 (Actual)
Primary Completion Date
March 1, 2009 (Actual)
Study Completion Date
September 30, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Buenos Aires

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
Panic disorder, Exercise, Alprazolam, Aerobic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alprazolam
Arm Type
Active Comparator
Arm Description
Patients assigned to the pharmacological plan
Arm Title
Alprazolam + Aerobic exercise
Arm Type
Active Comparator
Arm Description
Patients assigned to mix plan
Intervention Type
Drug
Intervention Name(s)
Alprazolam
Other Intervention Name(s)
Non exercise group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Alprazolam + Aerobic exercise
Other Intervention Name(s)
Exercise group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)
Description
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).
Time Frame
Baseline and 12 weeks
Title
Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo G Rudelir, MD
Organizational Affiliation
Psychiatry and Mental Health Department at University of Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
1425
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15957014
Citation
Toro Martinez E, Rudelir M. [Assessment of suicide risk: clinical and legal aspects]. Vertex. 2005 May-Jun;16(61):196-205. Spanish.
Results Reference
background
Links:
URL
https://www.fmed.uba.ar/index.php/departamentos_y_catedras/departamento-de-psiquiatria-y-salud-mental/autoridades-y-cuerpo-docente
Description
Psychiatry and Mental Health Department at University of Buenos Aires

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Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment

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