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Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00219349
First received: September 14, 2005
Last updated: April 11, 2012
Last verified: April 2012
Results First Received: February 29, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Generalized Anxiety Disorder
Interventions: Behavioral: Cognitive Behavioral-Therapy
Drug: escitalopram

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cognitive-behavioral Therapy 14 weekly sessions of individual cognitive-behavioral therapy

Participant Flow for 2 periods

Period 1:   Cognitive Behavioral Therapy Phase
    Cognitive-behavioral Therapy  
STARTED     25  
COMPLETED     15  
NOT COMPLETED     10  
Lost to Follow-up                 6  
Withdrawal by Subject                 2  
Protocol Violation                 2  

Period 2:   Escitalopram Phase
    Cognitive-behavioral Therapy  
STARTED     15 [1]
COMPLETED     4  
NOT COMPLETED     11  
Withdrawal by Subject                 4  
Physician Decision                 7  
[1] 7 responders to CBT were ineligible to start and 1 declined, leaving 7 who started escitalopram



  Baseline Characteristics
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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
Cognitive-behavioral Therapy 14 weekly sessions of individual cognitive-behavioral therapy

Baseline Measures
    Cognitive-behavioral Therapy  
Number of Participants  
[units: participants]
  25  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  41  ± 11.8  
Gender  
[units: participants]
 
Female     11  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     25  



  Outcome Measures

1.  Primary:   Change in Hamilton Anxiety Rating Scale Score   [ Time Frame: week 14 to week 26 ]

2.  Primary:   Clinical Global Impressions-Improvement Index   [ Time Frame: week 26 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Primary:   Clinical Global Impressions-Severity Index   [ Time Frame: week 14 to week 26 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Primary:   GAD Severity Scale   [ Time Frame: week 14 to week 26 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Primary:   Penn State Worry Questionnaire   [ Time Frame: week 14 to week 26 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Primary:   State-Trait Anxiety Inventory   [ Time Frame: week 14 to week 26 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Primary:   Change in Hamilton Anxiety Scale Score   [ Time Frame: week 14 to week 26 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Hamilton Rating Scale for Depression   [ Time Frame: week 14 to week 26 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Beck Depression Inventory-II   [ Time Frame: week 14 to week 26 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Franklin Schneier MD
Organization: New York State Psychiatric Institute
phone: 2125435368
e-mail: fschneier@nyspi.columbia.edu


Publications of Results:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00219349     History of Changes
Other Study ID Numbers: #4941
Study First Received: September 14, 2005
Results First Received: February 29, 2012
Last Updated: April 11, 2012
Health Authority: United States: Food and Drug Administration