Phase 4
N=150
Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment
Panic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00803400 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Dec 2008
Primary outcome: Primary: Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale — 22.59; 22.73 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Alprazolam (Drug); Alprazolam + Aerobic exercise (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of Buenos Aires
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale |
22.59; 22.73 | <0.001 sig |
| SECONDARY Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) |
4.05; 4.06 | — |
| SECONDARY Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) |
2.70; 1.86 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00803400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.