Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment
Condition: Panic Disorder
MeSH terms: Panic Disorder
Intervention: Alprazolam; Alprazolam + Aerobic exercise
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.; 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 MeSH terms: Alprazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Panic disorder; Exercise; Alprazolam; Aerobic

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.
    

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.