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Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment (AEIPDT)

This study has been completed.
Sponsor:
Information provided by:
University of Buenos Aires
ClinicalTrials.gov Identifier:
NCT00803400
First received: November 7, 2008
Last updated: April 21, 2009
Last verified: April 2009
History of Changes
Results First Received: November 7, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Panic Disorder
Interventions: Drug: Alprazolam
Drug: Alprazolam + Aerobic exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
180 patients were preselected for the study and 150 were eligible for the study. They were outpatients from the office practice and were recruited from March 2005 to July 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
30 selected patients were not included: 12 did not match the 20 points for the Hamilton Anxiety Scale; 10 had history of medical diseases (5 of hypothyroidism, 4 of hypertension, and 1 of chronic fatigue syndrome); 8 had other associated psychiatric diseases: (5 had major depressive disorder and 3 had social anxiety disorder).

Reporting Groups
  Description
Alprazolam No text entered.
Alprazolam + Aerobic Exercise No text entered.

Participant Flow:   Overall Study
    Alprazolam     Alprazolam + Aerobic Exercise  
STARTED     75     75  
COMPLETED     55     51  
NOT COMPLETED     20     24  



  Baseline Characteristics
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Reporting Groups
  Description
Alprazolam No text entered.
Alprazolam + Aerobic Exercise No text entered.
Total Total of all reporting groups

Baseline Measures
    Alprazolam     Alprazolam + Aerobic Exercise     Total  
Number of Participants  
[units: participants]
 		  75     75     150  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     75     75     150  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  34.01  ± 8.07     35.68  ± 7.67     34.85  ± 7.89  
Gender  
[units: participants]
 		     
Female     57     55     112  
Male     18     20     38  
Region of Enrollment  
[units: participants]
 		     
Argentina     75     75     150  



  Outcome Measures
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1.  Primary:   Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale   [ Time Frame: Baseline and 12 weeks ]

Measure Type Primary
Measure Title Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale
Measure Description 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).
Time Frame Baseline and 12 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Alprazolam No text entered.
Alprazolam + Aerobic Exercise No text entered.

Measured Values
    Alprazolam     Alprazolam + Aerobic Exercise  
Number of Participants Analyzed  
[units: participants]
 		  75     75  
Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale  
[units: Units on a scale]
Mean ± Standard Deviation 		  22.59  ± 2.09     22.73  ± 1.98  

No statistical analysis provided for Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale



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

Measure Type Secondary
Measure Title Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)
Measure Description 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).
Time Frame Baseline and 12 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Alprazolam No text entered.
Alprazolam + Aerobic Exercise No text entered.

Measured Values
    Alprazolam     Alprazolam + Aerobic Exercise  
Number of Participants Analyzed  
[units: participants]
 		  75     75  
Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)  
[units: Units on a scale]
Mean ± Standard Deviation 		  4.05  ± 0.23     4.06  ± 0.24  

No statistical analysis provided for Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)



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

Measure Type Secondary
Measure Title Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)
Measure Description 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.
Time Frame Baseline and 12 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
For this outcome the baseline number of participants is zero as at the first visit patients have not received any treatment yet, thus they cannot be assessed with a scale that measures improvement at their first visit. This scale will only be applied along weeks 2, 4, 8, and 12, after patients have received their corresponding treatments.

Reporting Groups
  Description
Alprazolam No text entered.
Alprazolam + Aerobic Exercise No text entered.

Measured Values
    Alprazolam     Alprazolam + Aerobic Exercise  
Number of Participants Analyzed  
[units: participants]
 		  0     0  
Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)  
[units: Units on a scale]
Mean ± Standard Deviation 		       

No statistical analysis provided for Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Panic patients may sometimes be reluctant to use medication. This could lead to early drop outs.

Possible difficulties in following the exercise protocol.

 


Results Point of Contact:  
Name/Title: Dr. Marcelo Rudelir
Organization: Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health
phone: 54 11 48254740
e-mail: mrudelir@hotmail.com


Publications:


Responsible Party: Dr.Marcelo Rudelir, Ph D, Psychiatry Academic Unit at J.A. Fernandez Hospital of Buenos Aires
ClinicalTrials.gov Identifier: NCT00803400     History of Changes
Other Study ID Numbers: UDHFMEDUBA0709
Study First Received: November 7, 2008
Results First Received: November 7, 2008
Last Updated: April 21, 2009
Health Authority: Argentina: Human Research Bioethics Committee