Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00220701
First received: September 21, 2005
Last updated: November 19, 2014
Last verified: November 2007
Results First Received: November 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dysthymic Disorder
Intervention: Drug: Lexapro (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
Escitalopram

Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Placebo

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)


Participant Flow:   Overall Study
    Escitalopram     Placebo  
STARTED     17     17  
COMPLETED     12     13  
NOT COMPLETED     5     4  
Lost to Follow-up                 5                 4  



  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
Escitalopram

Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Placebo

inactive comparator

Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Total Total of all reporting groups

Baseline Measures
    Escitalopram     Placebo     Total  
Number of Participants  
[units: participants]
  17     17     34  
Age  
[units: years]
Mean (Standard Deviation)
  43.88  (9.92)     43.59  (11.33)     43.74  (10.49)  
Gender  
[units: participants]
     
Female     6     11     17  
Male     11     6     17  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hamilton-Depression Rating Scale (HDRS-24 Items)   [ Time Frame: Week 12 ]

2.  Primary:   Hamilton-Depression Rating Scale (HDRS-24 Items)   [ Time Frame: Baseline ]

3.  Secondary:   Clinical Global Impressions - Severity (CGI-S)   [ Time Frame: Week 12 ]

4.  Secondary:   Beck Depression Inventory (BDI)   [ Time Frame: Baseline ]

5.  Secondary:   Clinical Global Impressions - Severity (CGI-S)   [ Time Frame: Baseline ]

6.  Secondary:   Beck Depression Inventory (BDI)   [ Time Frame: Week 12 ]

7.  Secondary:   Clinical Global Impressions - Improvement (CGI-I)   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2014   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
Small double blinded study with limited power.


  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: David Hellerstein MD
Organization: NY State Psychiatric Institute
phone: 6467748000
e-mail: hellers@nyspi.columbia.edu


Publications of Results:

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00220701     History of Changes
Other Study ID Numbers: LXP-MD-34
Study First Received: September 21, 2005
Results First Received: November 19, 2014
Last Updated: November 19, 2014
Health Authority: United States: Institutional Review Board