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Trial record 8 of 531 for:    ESCITALOPRAM AND Disorders

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

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ClinicalTrials.gov Identifier: NCT00219349
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 9, 2012
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Generalized Anxiety Disorder
Interventions Behavioral: Cognitive Behavioral Therapy
Drug: escitalopram
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cognitive-behavioral Therapy
Hide Arm/Group Description 14 weekly sessions of individual cognitive-behavioral therapy
Period Title: Cognitive Behavioral Therapy Phase
Started 25
Completed 15
Not Completed 10
Reason Not Completed
Lost to Follow-up             6
Withdrawal by Subject             2
Protocol Violation             2
Period Title: Escitalopram Phase
Started 7 [1]
Completed 4
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
[1]
7 responders to CBT were ineligible to start and 1 declined, leaving 7 who started escitalopram
Arm/Group Title Cognitive-behavioral Therapy
Hide Arm/Group Description 14 weekly sessions of individual cognitive-behavioral therapy
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
41  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
11
  44.0%
Male
14
  56.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Change in Hamilton Anxiety Rating Scale Score
Hide Description The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.
Time Frame week 14 to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
see above: Patients who completed the CBT phase and started escitalopram treatment
Arm/Group Title Patients Who Started Escitalopram
Hide Arm/Group Description:
Patients who completed the CBT phase and started escitalopram phase treatment
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.4  (10.1)
2.Primary Outcome
Title Change in Clinical Global Impressions-Severity Index
Hide Description 7 point scale of overall severity of psychopathology from 1 mildest to 7 most severe.
Time Frame week 14 to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Started Escitalopram
Hide Arm/Group Description:
Patients who completed the CBT phase and started escitalopram phase treatment
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.4  (1.0)
3.Primary Outcome
Title Change in Generalized Anxiety Disorder Severity Scale
Time Frame week 14 to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Started Escitalopram
Hide Arm/Group Description:
Patients who completed the CBT phase and started escitalopram phase treatment
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.8  (3.2)
4.Primary Outcome
Title Change in Penn State Worry Questionnaire
Hide Description total score (of 16 items) ranging from 16 (least worry) to 80 (most worry)
Time Frame week 14 to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Started Escitalopram
Hide Arm/Group Description:
Patients who completed the CBT phase and started escitalopram phase treatment
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.8  (11.2)
5.Primary Outcome
Title Change in State-Trait Anxiety Inventory, State Subscale
Hide Description only the total score of the state anxiey subscale was used. Range is from 20 (mildest) to 80 (most severe)
Time Frame week 14 to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Started Escitalopram
Hide Arm/Group Description:
Patients who completed the CBT phase and started escitalopram phase treatment
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.4  (11.6)
6.Secondary Outcome
Title Clinical Global Impressions-Improvement Index
Hide Description This is a single item rating overall symptomatic improvement. Range is 0 (very much worse) to 7 (very much improved)
Time Frame week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Started Escitalopram
Hide Arm/Group Description:
Patients who completed the CBT phase and started escitalopram phase treatment
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.0  (1.5)
7.Secondary Outcome
Title Change in Hamilton Rating Scale for Depression
Hide Description 24 item version of this standard depression scale, total score ranges from 0 (not depressed) to 58 (most severe)
Time Frame week 14 to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Started Escitalopram
Hide Arm/Group Description:
Patients who completed the CBT phase and started escitalopram phase treatment
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.3  (5.9)
8.Secondary Outcome
Title Change in Beck Depression Inventory-II
Hide Description total score ranges from 0 (not depressed) to 63 (most severe)
Time Frame week 14 to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Who Started Escitalopram
Hide Arm/Group Description:
Patients who completed the CBT phase and started escitalopram phase treatment
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.7  (10.3)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description all subject entered
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%) # Events
Total   0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1
Affected / at Risk (%) # Events
Total   2/25 (8.00%)    
Nervous system disorders   
insomnia *  2/25 (8.00%)  5
*
Indicates events were collected by non-systematic assessment
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
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00219349     History of Changes
Other Study ID Numbers: #4941
First Submitted: September 14, 2005
First Posted: September 22, 2005
Results First Submitted: February 29, 2012
Results First Posted: May 9, 2012
Last Update Posted: December 19, 2017