REL-1017 (Esmethadone) as Adjunctive Treatment in Patients With Major Depressive Disorder: A Phase 2a Randomized Double-Blind Trial
Abstract
METHODS
Study Design
Participants
Randomization and Masking
Procedures
Outcomes
Statistical Analysis
RESULTS
Characteristic | Placebo (N=22) | REL-1017 25 mg (N=19) | REL-1017 50 mg (N=21) | All Patients (N=62) | ||||
---|---|---|---|---|---|---|---|---|
Mean | SD | Mean | SD | Mean | SD | Mean | SD | |
Age (years)b | 49.7 | 11.1 | 49.4 | 12.4 | 48.6 | 10.9 | 49.2 | 11.3 |
N | % | N | % | N | % | N | % | |
Sex | ||||||||
Male | 11 | 50.0 | 11 | 57.9 | 12 | 57.1 | 34 | 54.8 |
Female | 11 | 50.0 | 8 | 42.1 | 9 | 42.9 | 28 | 45.2 |
Ethnicity | ||||||||
Hispanic or Latino | 1 | 4.5 | 1 | 5.3 | 0 | 0.0 | 2 | 3.2 |
Not Hispanic or Latino | 21 | 95.5 | 18 | 94.7 | 21 | 100.0 | 60 | 96.8 |
Race | ||||||||
Asian | 0 | 0 | 0 | 0 | 1 | 4.8 | 1 | 1.6 |
Black or African American | 13 | 59.1 | 13 | 68.4 | 13 | 61.9 | 39 | 62.9 |
Caucasian | 9 | 40.9 | 6 | 31.6 | 7 | 33.3 | 22 | 35.5 |
Mean | SD | Mean | SD | Mean | SD | Mean | SD | |
Body mass indexc | 29.02 | 4.27 | 27.66 | 3.33 | 27.66 | 5.00 | 28.15 | 4.26 |
Baseline HAM-D score | 25.6 | 3.5 | 25.1 | 3.5 | 25.0 | 3.8 | 25.3 | 3.6 |
Placebo (N=23) | REL-1017 25 mg (N=19) | REL-1017 50 mg (N=21) | All Patients (N=62) | |||||
---|---|---|---|---|---|---|---|---|
Variable | N | % | N | % | N | % | N | % |
Patients with a serious adverse event | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
Patients with a severe treatment-emergent adverse event | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
Patients with at least one adverse event | 12 | 54.5 | 9 | 47.4 | 15 | 71.4 | 36 | 58.1 |
Treatment-emergent adverse events occurring in three or more patients | ||||||||
Constipation | 3 | 13.6 | 1 | 5.3 | 3 | 14.3 | 7 | 11.3 |
Nausea | 2 | 9.1 | 1 | 5.3 | 2 | 9.5 | 5 | 8.1 |
Diarrhea | 3 | 13.6 | 0 | 0.0 | 0 | 0.0 | 3 | 4.8 |
Headache | 3 | 13.6 | 2 | 10.5 | 3 | 14.3 | 8 | 12.9 |
Somnolence | 2 | 9.1 | 1 | 5.3 | 1 | 4.8 | 4 | 6.5 |
Dizziness | 1 | 4.5 | 1 | 5.3 | 1 | 4.8 | 3 | 4.8 |
Back pain | 0 | 0.0 | 1 | 5.3 | 2 | 9.5 | 3 | 4.8 |
Measure, Time Point, and Group | N | Least Square Meanb | SE | Difference of Least Square Mean Drug Versus Placeboc | 90% CI | Effect Sized | pe |
---|---|---|---|---|---|---|---|
MADRS | |||||||
Day 7 | |||||||
Placebo | 21 | –8.7 | 2.3 | ||||
REL-1017 25 mg | 19 | –17.4 | 2.5 | –8.7 | –14.3, –3.1 | 0.8 | 0.0122 |
REL-1017 50 mg | 21 | –15.9 | 2.4 | –7.2 | –12.7, –1.8 | 0.7 | 0.0308 |
Day 14 | |||||||
Placebo | 20 | –7.4 | 2.4 | ||||
REL-1017 25 mg | 16 | –16.8 | 2.7 | –9.4 | –15.4, –3.5 | 0.9 | 0.0103 |
REL-1017 50 mg | 18 | –17.8 | 2.6 | –10.4 | –16.1, –4.6 | 1.0 | 0.0039 |
SDQ | |||||||
Day 7 | |||||||
Placebo | 21 | –37.9 | 6.4 | ||||
REL-1017 25 mg | 19 | –52.4 | 7.1 | –14.5 | –30.0, 1.0 | 0.5 | 0.1237 |
REL-1017 50 mg | 21 | –52.9 | 6.6 | –15.0 | –30.1, 0.1 | 0.5 | 0.1017 |
Day 14 | |||||||
Placebo | 20 | –31.8 | 5.6 | ||||
REL-1017 25 mg | 16 | –55.0 | 6.4 | –23.2 | –36.9, –9.4 | 0.9 | 0.0066 |
REL-1017 50 mg | 18 | –58.6 | 6.0 | –26.8 | –40.1, –13.5 | 1.1 | 0.0014 |
CGI-S | |||||||
Day 7 | |||||||
Placebo | 21 | –0.8 | 0.3 | ||||
REL-1017 25 mg | 19 | –1.7 | 0.3 | –1.0 | –1.6, –0.3 | 0.7 | 0.0245 |
REL-1017 50 mg | 21 | –1.7 | 0.3 | –0.9 | –1.6, –0.2 | 0.7 | 0.0253 |
Day 14 | |||||||
Placebo | 20 | –0.7 | 0.3 | ||||
REL-1017 25 mg | 16 | –1.6 | 0.3 | –0.9 | –1.7, –0.2 | 0.7 | 0.0454 |
REL-1017 50 mg | 18 | –2.0 | 0.3 | –1.3 | –2.0, –0.6 | 0.9 | 0.0043 |
CGI-I | |||||||
Day 7 | |||||||
Placebo | 21 | 3.2 | 0.2 | ||||
REL-1017 25 mg | 19 | 2.4 | 0.2 | –0.8 | –1.3, –0.2 | 0.8 | 0.0177 |
REL-1017 50 mg | 21 | 2.3 | 0.2 | –0.9 | –1.4, –0.3 | 0.9 | 0.0072 |
Day 14 | |||||||
Placebo | 20 | 3.3 | 0.3 | ||||
REL-1017 25 mg | 16 | 2.6 | 0.3 | –0.7 | –1.3, 0.0 | 0.6 | 0.0895 |
REL-1017 50 mg | 18 | 2.3 | 0.3 | –1.0 | –1.6, –0.4 | 0.8 | 0.0109 |
DISCUSSION
Footnotes
Supplementary Material
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