Trial Outcomes & Findings for Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram (NCT NCT00183677)

Last Updated: 2017-01-04

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

97 participants

Primary outcome timeframe

Measured at Week 12

Results posted on

2017-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	Open Label Escitalopram Participants will receive treatment with escitalopram.
Overall Study STARTED	97
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	44

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Escitalopram n=97 Participants Participants will receive treatment with escitalopram.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.54 years STANDARD_DEVIATION 13.42 • n=5 Participants
Gender Female	42 Participants n=5 Participants
Gender Male	55 Participants n=5 Participants
Region of Enrollment United States	97 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Open Label Escitalopram n=53 Participants Participants received open treatment with escitalopram.
Responder and Remission Status (%), Based on the Depression Rating Scale Score Clinical Responders	36 participants
Responder and Remission Status (%), Based on the Depression Rating Scale Score Clinical Remitters	32 participants

Adverse Events

Open Label Escitalopram

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label Escitalopram n=97 participants at risk Participants will receive treatment with escitalopram.
Psychiatric disorders Fatigue	23.7% 23/97 • Number of events 23 • Adverse event data were collected over 12 weeks of participation in the study. All gastrointestinal symptoms (e.g., nausea, diarrhea) were collected under the category gastrointestinal upset ("GI upset")
Gastrointestinal disorders GI Upset	17.5% 17/97 • Number of events 17 • Adverse event data were collected over 12 weeks of participation in the study. All gastrointestinal symptoms (e.g., nausea, diarrhea) were collected under the category gastrointestinal upset ("GI upset")
General disorders Headache	11.3% 11/97 • Number of events 11 • Adverse event data were collected over 12 weeks of participation in the study. All gastrointestinal symptoms (e.g., nausea, diarrhea) were collected under the category gastrointestinal upset ("GI upset")
General disorders Insomnia/Sleep Disturbance	11.3% 11/97 • Number of events 11 • Adverse event data were collected over 12 weeks of participation in the study. All gastrointestinal symptoms (e.g., nausea, diarrhea) were collected under the category gastrointestinal upset ("GI upset")
Reproductive system and breast disorders Sexual Side Effects	10.3% 10/97 • Number of events 10 • Adverse event data were collected over 12 weeks of participation in the study. All gastrointestinal symptoms (e.g., nausea, diarrhea) were collected under the category gastrointestinal upset ("GI upset")
Psychiatric disorders Agitation	6.2% 6/97 • Number of events 6 • Adverse event data were collected over 12 weeks of participation in the study. All gastrointestinal symptoms (e.g., nausea, diarrhea) were collected under the category gastrointestinal upset ("GI upset")
General disorders Decreased Appetite	5.2% 5/97 • Number of events 5 • Adverse event data were collected over 12 weeks of participation in the study. All gastrointestinal symptoms (e.g., nausea, diarrhea) were collected under the category gastrointestinal upset ("GI upset")

Additional Information

Dan Iosifescu, MD, MSc

Massachusetts General Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place