Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00803400
• Date of registration: 07/11/2008
• Prospective Registration: No
• Primary sponsor: University of Buenos Aires
• Public title: Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment AEIPDT
• Scientific title: Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: a Clinical Randomized Trial
• Date of first enrolment: July 2005
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00803400
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Argentina

Contacts

• Name: Marcelo G Rudelir, MD
• Affiliation: Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Psychiatry

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Panic Disorder

Intervention(s)

Drug: Alprazolam + Aerobic exercise

Drug: Alprazolam

Primary Outcome(s)

Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale [Time Frame: Baseline and 12 weeks]

Secondary Outcome(s)

Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) [Time Frame: Baseline and 12 weeks]

Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) [Time Frame: Baseline and 12 weeks]

Secondary ID(s)

UDHFMEDUBA0709

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/12/2008
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00803400