Clinical trial NCT00803400: Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment
Official title: Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: a Clinical Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Panic Disorder
Keywords: Panic disorder
Exercise
Alprazolam
Aerobic
Lead sponsor: University of Buenos Aires
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)
timeFrame: Baseline and 12 weeks
measure: Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health
state: Capital Federal
Study officials:
affiliation: Psychiatry and Mental Health Department at University of Buenos Aires
name: Marcelo G Rudelir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toro Martinez E, Rudelir M. [Assessment of suicide risk: clinical and legal aspects]. Vertex. 2005 May-Jun;16(61):196-205. Spanish.