Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment (AEIPDT)
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|ClinicalTrials.gov Identifier: NCT00803400|
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : December 5, 2008
Last Update Posted : May 7, 2009
|Condition or disease||Intervention/treatment||Phase|
|Panic Disorder||Drug: Alprazolam Drug: Alprazolam + Aerobic exercise||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: a Clinical Randomized Trial|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||October 2008|
|Active Comparator: Alprazolam||
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.
|Active Comparator: Alprazolam + Aerobic exercise||
Drug: Alprazolam + Aerobic exercise
The patients assigned to exercise have to pass an ergometric test to determine the functional capacity expressed in Metabolic Equivalents of Task (METs), and their maximum heart rates to standardize the 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.
At the same time they have to follow a protocolized aerobic exercise plan for this study 3 times a week for 12 weeks.
The type of selected exercise consists of a rapid walk (both in not inclined treadmill or natural courses) for 30 minutes divided in stages.
After each stage the patient has to control his own heart frequency that has to be maintained between 50 and 75% of their maximum not to turn to an anaerobic condition, according to the American Cardiological Association.
- Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale [ Time Frame: Baseline and 12 weeks ]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).
- Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) [ Time Frame: Baseline and 12 weeks ]The Clinical Global Impression Severity scale is a 7 point ordinal scale that rates the severity of the patient's illness, assessing on the severity of a patient's mental illness. It ranges from 1 to 7 (1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; 7, extremely ill).
- Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) [ Time Frame: Baseline and 12 weeks ]The Clinical Global Impression Improvement Scale is a 7 point ordinal scale that assesses how much the patient's illness has improved or worsened relative to a baseline state before the intervention. Rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803400
|Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health|
|Buenos Aires, Capital Federal, Argentina, 1425|
|Principal Investigator:||Marcelo G Rudelir, MD||Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Psychiatry|