Trial Outcomes & Findings for Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder (NCT NCT00807248)

Results Overview

The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

490 participants

Primary outcome timeframe

Baseline to 8 weeks

Results posted on

2012-12-17

Participant Flow

The patients were recruited from specialist inpatient and outpatient clinics.

Participant milestones

Participant milestones
Measure	Placebo (Orally, Once Daily)	Escitalopram 20 mg and Placebo (Orally, Once Daily)	Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)	Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Overall Study STARTED	71	140	139	140
Overall Study COMPLETED	50	128	121	126
Overall Study NOT COMPLETED	21	12	18	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (Orally, Once Daily)	Escitalopram 20 mg and Placebo (Orally, Once Daily)	Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)	Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)
Overall Study Adverse Event	1	2	2	6
Overall Study Lack of Efficacy	14	4	8	3
Overall Study Protocol Violation	0	1	1	0
Overall Study Withdrawal of Consent	5	5	5	5
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Other Reason	0	0	2	0

Baseline Characteristics

Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (Orally, Once Daily) n=71 Participants	Escitalopram 20 mg and Placebo (Orally, Once Daily) n=140 Participants	Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily) n=139 Participants	Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily) n=140 Participants	Total n=490 Participants Total of all reporting groups
Age Continuous	42.6 years STANDARD_DEVIATION 11.6 • n=5 Participants	41.6 years STANDARD_DEVIATION 12.6 • n=7 Participants	42.6 years STANDARD_DEVIATION 11.8 • n=5 Participants	41.5 years STANDARD_DEVIATION 10.5 • n=4 Participants	42.0 years STANDARD_DEVIATION 11.7 • n=21 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	96 Participants n=7 Participants	96 Participants n=5 Participants	93 Participants n=4 Participants	338 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	44 Participants n=7 Participants	43 Participants n=5 Participants	47 Participants n=4 Participants	152 Participants n=21 Participants
Montgomery and Åsberg Depression Rating Scale (MADRS)	34.7 Scores on a scale STANDARD_DEVIATION 4.2 • n=5 Participants	35.4 Scores on a scale STANDARD_DEVIATION 4.3 • n=7 Participants	35.3 Scores on a scale STANDARD_DEVIATION 3.4 • n=5 Participants	34.7 Scores on a scale STANDARD_DEVIATION 3.8 • n=4 Participants	35.1 Scores on a scale STANDARD_DEVIATION 3.9 • n=21 Participants
Hospital Anxiety and Depression Scale (HADS)	27.5 Scores on a scale STANDARD_DEVIATION 5.9 • n=5 Participants	28.2 Scores on a scale STANDARD_DEVIATION 5.3 • n=7 Participants	28.1 Scores on a scale STANDARD_DEVIATION 5.5 • n=5 Participants	27.4 Scores on a scale STANDARD_DEVIATION 5.5 • n=4 Participants	27.8 Scores on a scale STANDARD_DEVIATION 5.5 • n=21 Participants
Insomnia Severity Index (ISI)	18.4 Scores on a scale STANDARD_DEVIATION 5.0 • n=5 Participants	18.6 Scores on a scale STANDARD_DEVIATION 4.7 • n=7 Participants	18.2 Scores on a scale STANDARD_DEVIATION 4.4 • n=5 Participants	18.1 Scores on a scale STANDARD_DEVIATION 4.8 • n=4 Participants	18.3 Scores on a scale STANDARD_DEVIATION 4.7 • n=21 Participants
Sheehan Disability Scale (SDS): Family Subscale	7.0 Scores on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	7.1 Scores on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	7.2 Scores on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	6.9 Scores on a scale STANDARD_DEVIATION 1.4 • n=4 Participants	7.1 Scores on a scale STANDARD_DEVIATION 1.4 • n=21 Participants
SDS: Work Subscale	7.3 Scores on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	7.4 Scores on a scale STANDARD_DEVIATION 1.3 • n=7 Participants	7.3 Scores on a scale STANDARD_DEVIATION 1.5 • n=5 Participants	7.0 Scores on a scale STANDARD_DEVIATION 1.4 • n=4 Participants	7.2 Scores on a scale STANDARD_DEVIATION 1.4 • n=21 Participants
SDS: Social Subscale	7.0 Scores on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	7.1 Scores on a scale STANDARD_DEVIATION 1.4 • n=7 Participants	7.1 Scores on a scale STANDARD_DEVIATION 1.5 • n=5 Participants	6.9 Scores on a scale STANDARD_DEVIATION 1.6 • n=4 Participants	7.0 Scores on a scale STANDARD_DEVIATION 1.5 • n=21 Participants
Clinical Global Impression - Severity of Illness (CGI-S)	4.4 Scores on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	4.5 Scores on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	4.3 Scores on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	4.4 Scores on a scale STANDARD_DEVIATION 0.9 • n=4 Participants	4.4 Scores on a scale STANDARD_DEVIATION 0.9 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Population: Mean change from baseline to Week 8: Full-analysis Set (FAS), Last Observation Carried Forward (LOCF), Analysis of Covariance (ANCOVA)

The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.