Text Size

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
  Hide Participant Flow

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
  Show Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

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

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

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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