Escitalopram in Adult Patients With Major Depressive Disorder

This study has been completed.

Study NCT00668525 Information provided by Forest Laboratories

First Received on April 28, 2008. Last Updated on May 7, 2010 History of Changes

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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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.

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

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor can review results communications prior to public release & can embargo communications re: results for 90 days from time submitted to sponsor for review. PI shall not disclose sponsor’s confidential info. Upon sponsor’s request, PI shall delete any proprietary info & shall not include raw data in pub. On sponsor’s request, PI shall delay submission for any pub while sponsor files patent apps. If trial is multi-center, PI agrees that first publication shall be a multi-center pub.

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
No text entered.

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