Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment

NCT00803400 | Completed Phase 4 Results FDA Drug

• 1 other identifier: UDHFMEDUBA0709
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder

Keywords

Panic disorder; Exercise; Alprazolam; Aerobic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)

  Baseline and 12 weeks

• Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)

  Baseline and 12 weeks

Study Arms (2)

Alprazolam

ACTIVE COMPARATOR

Patients assigned to the pharmacological plan

Drug: Alprazolam

Alprazolam + Aerobic exercise

ACTIVE COMPARATOR

Patients assigned to mix plan

Drug: Alprazolam + Aerobic exercise

Interventions

Alprazolam 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.

Also known as: Non exercise group

Alprazolam

Alprazolam + Aerobic exercise 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).

Also known as: Exercise group

Alprazolam + Aerobic exercise

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Buenos Aires: lead

Study Sites (1)

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

Buenos Aires, Buenos Aires F.D., 1425, Argentina

Location

Related Publications (1)

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

  PMID: 15957014 BACKGROUND

Related Links

• Psychiatry and Mental Health Department at University of Buenos Aires

MeSH Terms

Conditions

Panic Disorder; Motor Activity

Interventions

Alprazolam; Exercise

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Panic patients may sometimes be reluctant to use medication. This could lead to early drop outs. Possible difficulties in following the exercise protocol.

Results Point of Contact

• Title: Dr. Marcelo Rudelir
• Organization: Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health

mrudelir@hotmail.com

54 11 48254740

Study Officials

• Marcelo G Rudelir, MD

  Psychiatry and Mental Health Department at University of Buenos Aires

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: December 5, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: September 30, 2009
• Last Updated: August 19, 2021
• Results First Posted: December 5, 2008

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)