Trial Outcomes & Findings for Brain GABA Levels and Treatment Response in Major Depressive Disorder (NCT NCT00464711)

Last Updated: 2017-01-04

Results Overview

The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as \> 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score \< 8. 40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	Escitalopram 40 subjects met inclusion/exclusion criteria and started treatment with escitalopram
Overall Study STARTED	40
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain GABA Levels and Treatment Response in Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram n=40 Participants 40 subjects met inclusion/exclusion criteria and started study treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38.675 years STANDARD_DEVIATION 14.08 • n=5 Participants
Gender Female	21 Participants n=5 Participants
Gender Male	19 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 40 patients (21 female) with MDD enrolled in the 12 week study, 25 patients (15 Female) completed. Current analyses are based on completers only.

Outcome measures

Outcome measures
Measure	Open Label Escitalopram n=25 Participants All subjects were treated with open label escitalopram
Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores Clinical Response	16 participants
Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores Clinical Remission	14 participants

Adverse Events

Escitalopram

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Escitalopram n=40 participants at risk 40 subjects met inclusion/exclusion criteria and started study treatment
General disorders Insomnia	22.5% 9/40 • Number of events 9 • Adverse events were collected over 12 weeks of treatment.
Gastrointestinal disorders GI Upset	20.0% 8/40 • Number of events 8 • Adverse events were collected over 12 weeks of treatment.
General disorders Fatigue/Sedation	12.5% 5/40 • Number of events 5 • Adverse events were collected over 12 weeks of treatment.
General disorders Headache	10.0% 4/40 • Number of events 4 • Adverse events were collected over 12 weeks of treatment.
General disorders Sexual Side Effects	10.0% 4/40 • Number of events 4 • Adverse events were collected over 12 weeks of treatment.
General disorders Jitteriness/Agitation	5.0% 2/40 • Number of events 2 • Adverse events were collected over 12 weeks of treatment.
General disorders Decreased Appetite	5.0% 2/40 • Number of events 2 • Adverse events were collected over 12 weeks of treatment.
General disorders Increased sweatiness	5.0% 2/40 • Number of events 2 • Adverse events were collected over 12 weeks of treatment.
General disorders Increased Appetite	5.0% 2/40 • Number of events 2 • Adverse events were collected over 12 weeks of treatment.

Additional Information

Dr. Dan Iosifescu

Massachusetts General Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place