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Escitalopram in Adult Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00668525
First received: April 28, 2008
Last updated: May 7, 2010
Last verified: May 2010
Results First Received: March 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Escitalopram
Drug: Placebo

  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
Recruitment period was from 4/30/08 through 12/19/08 with last patient last visit on 2/24/09 at 45 centers in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A one-week single-blind placebo period was completed prior to randomization. Patients were then randomized in a 3:3:2 ratio to either escitalopram low dose, escitalopram high dose or placebo.

Reporting Groups
  Description
Escitalopram Low Dose Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Escitalopram High Dose Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Placebo Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.

Participant Flow:   Overall Study
    Escitalopram Low Dose     Escitalopram High Dose     Placebo  
STARTED     325 [1]   332 [1]   220 [1]
COMPLETED     248 [2]   239 [2]   167 [2]
NOT COMPLETED     77     93     53  
[1] The number of patients started are based on the Randomized Population.
[2] The number of patients completed are based on the Randomized Population.



  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 Low Dose Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Escitalopram High Dose Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Placebo Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Total Total of all reporting groups

Baseline Measures
    Escitalopram Low Dose     Escitalopram High Dose     Placebo     Total  
Number of Participants  
[units: participants]
  322     324     218     864  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     322     324     218     864  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.4  ± 12.3     40.4  ± 11.9     42.3  ± 12.7     41.3  ± 12.2  
Gender  
[units: participants]
       
Female     205     222     137     564  
Male     117     102     81     300  
Region of Enrollment  
[units: participants]
       
United States     322     324     218     864  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.   [ Time Frame: Change from baseline in MADRS total score at week 8 ]

2.  Secondary:   Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8   [ Time Frame: Change from baseline in HAM-D at week 8 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Carl Gommoll, MS
Organization: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
phone: 201-427-8000
e-mail: carl.gommoll@frx.com


No publications provided


Responsible Party: Carl Gommoll, Study Director, Forest Laboratories
ClinicalTrials.gov Identifier: NCT00668525     History of Changes
Other Study ID Numbers: SCT-MD-49
Study First Received: April 28, 2008
Results First Received: March 22, 2010
Last Updated: May 7, 2010
Health Authority: United States: Food and Drug Administration