Trial Outcomes & Findings for Safety and Efficacy Study Comparing ETS6103 With Amitriptyline in the Treatment of Major Depressive Disorder (MDD) (NCT NCT02014363)
NCT ID: NCT02014363
Last Updated: 2017-01-11
Results Overview
The mean difference in baseline-adjusted MADRS score at the end of treatment in the per protocol population using the last observation carried forward (LOCF) method. MADRS is used to assess the range of symptoms that are most frequently observed in patients with major depression. The MADRS test includes 10 items and uses a 0 to 6 severity scale, with higher scores indicating increasing depressive symptoms. The total MADRS score is derived by adding all the scores from the 10 items, meaning the lowest possible score is 0 and the highest possible is 60.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
164 participants
Primary outcome timeframe
Baseline (start of randomized treatment) and 8 weeks post start of treatment
Results posted on
2017-01-11
Participant Flow
Participant milestones
| Measure |
ETS6103 (Low Dose)
ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (low dose)
|
ETS6103 (High Dose)
ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (high dose)
|
Amitriptyline
Amitriptyline tablets (encapsulated) Standard dosing regime
Amitriptyline
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
55
|
|
Overall Study
COMPLETED
|
38
|
35
|
31
|
|
Overall Study
NOT COMPLETED
|
17
|
19
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study Comparing ETS6103 With Amitriptyline in the Treatment of Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
ETS6103 (Low Dose)
n=55 Participants
ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (low dose)
|
ETS6103 (High Dose)
n=54 Participants
ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (high dose)
|
Amitriptyline
n=55 Participants
Amitriptyline tablets (encapsulated) Standard dosing regime
Amitriptyline
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 12.74 • n=7 Participants
|
35.6 years
STANDARD_DEVIATION 11.95 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 12.18 • n=4 Participants
|
|
Gender
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Gender
Male
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (start of randomized treatment) and 8 weeks post start of treatmentPopulation: Per protocol population (all subjects of the full analysis set for whom no relevant protocol deviations were documented).
The mean difference in baseline-adjusted MADRS score at the end of treatment in the per protocol population using the last observation carried forward (LOCF) method. MADRS is used to assess the range of symptoms that are most frequently observed in patients with major depression. The MADRS test includes 10 items and uses a 0 to 6 severity scale, with higher scores indicating increasing depressive symptoms. The total MADRS score is derived by adding all the scores from the 10 items, meaning the lowest possible score is 0 and the highest possible is 60.
Outcome measures
| Measure |
ETS6103 (Low Dose)
n=44 Participants
ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (low dose)
|
ETS6103 (High Dose)
n=43 Participants
ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (high dose)
|
Amitriptyline
n=39 Participants
Amitriptyline tablets (encapsulated) Standard dosing regime
Amitriptyline
|
|---|---|---|---|
|
Change From Baseline in Baseline-adjusted (Montgomery-Asberg Depression Scale) MADRS Score at the End of Treatment.
|
-6.1396 Scores on a scale
Standard Error 1.64423
|
-6.0076 Scores on a scale
Standard Error 1.65174
|
-11.3762 Scores on a scale
Standard Error 1.7344
|
Adverse Events
ETS6103 (Low Dose)
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
ETS6103 (High Dose)
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Amitriptyline
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ETS6103 (Low Dose)
n=55 participants at risk
ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (low dose)
|
ETS6103 (High Dose)
n=54 participants at risk
ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (high dose)
|
Amitriptyline
n=55 participants at risk
Amitriptyline tablets (encapsulated) Standard dosing regime
Amitriptyline
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/55
|
1.9%
1/54 • Number of events 1
|
0.00%
0/55
|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
1/55 • Number of events 1
|
0.00%
0/54
|
0.00%
0/55
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/55
|
0.00%
0/54
|
1.8%
1/55 • Number of events 1
|
Other adverse events
| Measure |
ETS6103 (Low Dose)
n=55 participants at risk
ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (low dose)
|
ETS6103 (High Dose)
n=54 participants at risk
ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).
ETS6103 (high dose)
|
Amitriptyline
n=55 participants at risk
Amitriptyline tablets (encapsulated) Standard dosing regime
Amitriptyline
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/55
|
0.00%
0/54
|
9.1%
5/55 • Number of events 5
|
|
Gastrointestinal disorders
Gastro-oesophageal reflux disease
|
3.6%
2/55 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Psychiatric disorders
Abnormal dreams
|
12.7%
7/55 • Number of events 7
|
14.8%
8/54 • Number of events 8
|
5.5%
3/55 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
1.8%
1/55 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
9.1%
5/55 • Number of events 5
|
|
Psychiatric disorders
Nightmare
|
3.6%
2/55 • Number of events 2
|
7.4%
4/54 • Number of events 4
|
1.8%
1/55 • Number of events 1
|
|
Psychiatric disorders
Irritability
|
1.8%
1/55 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Headache
|
10.9%
6/55 • Number of events 6
|
9.3%
5/54 • Number of events 5
|
5.5%
3/55 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
3.6%
2/55 • Number of events 2
|
9.3%
5/54 • Number of events 5
|
7.3%
4/55 • Number of events 4
|
|
Nervous system disorders
Tremor
|
0.00%
0/55
|
0.00%
0/54
|
14.5%
8/55 • Number of events 8
|
|
Nervous system disorders
Somnolence
|
0.00%
0/55
|
1.9%
1/54 • Number of events 1
|
9.1%
5/55 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.5%
3/55 • Number of events 3
|
13.0%
7/54 • Number of events 8
|
0.00%
0/55
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.3%
4/55 • Number of events 4
|
1.9%
1/54 • Number of events 1
|
3.6%
2/55 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
1/55 • Number of events 1
|
9.3%
5/54 • Number of events 6
|
0.00%
0/55
|
|
Gastrointestinal disorders
Dry mouth
|
5.5%
3/55 • Number of events 3
|
13.0%
7/54 • Number of events 7
|
47.3%
26/55 • Number of events 26
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
3/55 • Number of events 4
|
11.1%
6/54 • Number of events 8
|
10.9%
6/55 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
10.9%
6/55 • Number of events 6
|
9.3%
5/54 • Number of events 7
|
0.00%
0/55
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/55 • Number of events 1
|
5.6%
3/54 • Number of events 3
|
7.3%
4/55 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/55
|
3.7%
2/54 • Number of events 2
|
7.3%
4/55 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
4/55 • Number of events 4
|
9.3%
5/54 • Number of events 5
|
0.00%
0/55
|
|
General disorders
Fatigue
|
5.5%
3/55 • Number of events 3
|
13.0%
7/54 • Number of events 7
|
7.3%
4/55 • Number of events 4
|
|
Investigations
Electrocardiogram QT prolonged
|
5.5%
3/55 • Number of events 3
|
1.9%
1/54 • Number of events 1
|
3.6%
2/55 • Number of events 2
|
|
Investigations
Blood pressure increased
|
0.00%
0/55
|
1.9%
1/54 • Number of events 1
|
5.5%
3/55 • Number of events 3
|
|
Investigations
Mean cell volume
|
1.8%
1/55 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
3/55 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
3.6%
2/55 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
4/55 • Number of events 4
|
1.9%
1/54 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/55 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
3.6%
2/55 • Number of events 2
|
0.00%
0/54
|
5.5%
3/55 • Number of events 3
|
|
Renal and urinary disorders
Proteinuria
|
1.8%
1/55 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
3.6%
2/55 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the 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.
- Publication restrictions are in place
Restriction type: OTHER