Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment

NCT ID: NCT00803400

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-01
• Study Completion Date: 2009-09-30

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.

Conditions

Panic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alprazolam

Patients assigned to the pharmacological plan

Group Type: ACTIVE_COMPARATOR

Alprazolam

Intervention Type: DRUG

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.

Alprazolam + Aerobic exercise

Patients assigned to mix plan

Group Type: ACTIVE_COMPARATOR

Alprazolam + Aerobic exercise

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Non exercise group; Exercise group

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

Dr.Marcelo Rudelir

Ph D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelo G Rudelir, MD

Role: PRINCIPAL_INVESTIGATOR

Psychiatry and Mental Health Department at University of Buenos Aires

Locations

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

Buenos Aires, Buenos Aires F.D., Argentina

Countries

Argentina

References

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

Reference Type: BACKGROUND

PMID: 15957014 (View on PubMed)

Related Links

https://www.fmed.uba.ar/index.php/departamentos_y_catedras/departamento-de-psiquiatria-y-salud-mental/autoridades-y-cuerpo-docente

Psychiatry and Mental Health Department at University of Buenos Aires

Other Identifiers

UDHFMEDUBA0709

Identifier Type: -

Identifier Source: org_study_id