Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram

• ClinicalTrials.gov Identifier: NCT00183677
• Recruitment Status: Completed
• First Posted: September 16, 2005
• Results First Posted: January 4, 2017
• Last Update Posted: January 4, 2017
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): David Mischoulon, MD, Massachusetts General Hospital

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Depression
• Intervention: Drug: Escitalopram
• Enrollment: 97

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Open Label Escitalopram
Arm/Group Description	Participants will receive treatment with escitalopram.
Period Title: Overall Study
Started	97
Completed	53
Not Completed	44

Baseline Characteristics

Arm/Group Title		Open Label Escitalopram
Arm/Group Description		Participants will receive treatment with escitalopram.
Overall Number of Baseline Participants		97
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	97 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	97 100.0%
	>=65 years	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	97 participants
		41.54 (13.42)
Gender; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	97 participants
	Female	42 43.3%
	Male	55 56.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	97 participants
		97

Outcome Measures

1. Primary Outcome

Title	Responder and Remission Status (%), Based on the Depression Rating Scale Score
Description	The Hamilton Depression Rating Scale, 17 items (HAMD-17, range 0-52) was used to measure changes in depression severity from baseline to endpoint. Clinical Responder status was defined as > 50% improvement (i.e., reduction) in HAMD-17 score from baseline to endpoint. Clinical Remission status was defined as HAMD-17 score < 8 at endpoint (week 12 visit).
Time Frame	Measured at Week 12

Outcome Measure Data

Analysis Population Description

97 patients with MDD (42 Female) enrolled in the 12 week study, 53 patients (27 Female) completed. Only completers were included in the primary outcome measure.

Arm/Group Title	Open Label Escitalopram
Arm/Group Description:	Participants received open treatment with escitalopram.
Overall Number of Participants Analyzed	53
Measure Type: Number; Unit of Measure: participants
Clinical Responders	36
Clinical Remitters	32

Adverse Events

Time Frame	Adverse event data were collected over 12 weeks of participation in the study.
Adverse Event Reporting Description	All gastrointestinal symptoms (e.g., nausea, diarrhea) were collected under the category gastrointestinal upset ("GI upset")
Arm/Group Title	Open Label Escitalopram
Arm/Group Description	Participants will receive treatment with escitalopram.
All-Cause Mortality
	Open Label Escitalopram
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Open Label Escitalopram
	Affected / at Risk (%)	# Events
Total	0/97 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Open Label Escitalopram
	Affected / at Risk (%)	# Events
Total	45/97 (46.39%)
Gastrointestinal disorders
GI Upset † [1]	17/97 (17.53%)	17
General disorders
Headache †	11/97 (11.34%)	11
Insomnia/Sleep Disturbance †	11/97 (11.34%)	11
Decreased Appetite †	5/97 (5.15%)	5
Psychiatric disorders
Fatigue † [2]	23/97 (23.71%)	23
Agitation † [3]	6/97 (6.19%)	6
Reproductive system and breast disorders
Sexual Side Effects † [4]	10/97 (10.31%)	10
† Indicates events were collected by systematic assessment; [1] GI upset includes report of GI upset, nausea, diarrhea, gas, stomach cramps, and/or indigestion; [2] Fatigue includes report of fatigue, sedation, drowsiness, hypersomnia, and/or lethargy.; [3] Agitation includes report of agitation, jitteriness, and internal restlessness.; [4] Sexual side effects include report of decreased sexual drive, anorgasmia, or erectile dysfunction.

Limitations and Caveats

[Not Specified]

More Information

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: Dan Iosifescu, MD, MSc
• Organization: Massachusetts General Hospital
• EMail: diosifescu@partners.org

• Responsible Party: David Mischoulon, MD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00183677
• Other Study ID Numbers: K23MH067111 ( U.S. NIH Grant/Contract )
• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Results First Submitted: September 22, 2011
• Results First Posted: January 4, 2017
• Last Update Posted: January 4, 2017