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Trial record 30 of 135 for:    AMITRIPTYLINE

Safety and Efficacy Study Comparing ETS6103 With Amitriptyline in the Treatment of Major Depressive Disorder (MDD) (ETS6103-003)

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ClinicalTrials.gov Identifier: NCT02014363
Recruitment Status : Completed
First Posted : December 18, 2013
Results First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
e-Therapeutics PLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: ETS6103 (low dose)
Drug: ETS6103 (high dose)
Drug: Amitriptyline
Enrollment 164
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ETS6103 (Low Dose) ETS6103 (High Dose) Amitriptyline
Hide Arm/Group Description

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) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).

ETS6103 (high dose)

Amitriptyline tablets (encapsulated) Standard dosing regime

Amitriptyline

Period Title: Overall Study
Started 55 54 55
Completed 38 35 31
Not Completed 17 19 24
Arm/Group Title ETS6103 (Low Dose) ETS6103 (High Dose) Amitriptyline Total
Hide Arm/Group Description

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) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).

ETS6103 (high dose)

Amitriptyline tablets (encapsulated) Standard dosing regime

Amitriptyline

Total of all reporting groups
Overall Number of Baseline Participants 55 54 55 164
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 54 participants 55 participants 164 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
55
 100.0%
54
 100.0%
55
 100.0%
164
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 54 participants 55 participants 164 participants
39.8  (11.85) 41.1  (12.74) 35.6  (11.95) 38.8  (12.18)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 54 participants 55 participants 164 participants
Female
16
  29.1%
14
  25.9%
19
  34.5%
49
  29.9%
Male
39
  70.9%
40
  74.1%
36
  65.5%
115
  70.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 55 participants 54 participants 55 participants 164 participants
55
 100.0%
54
 100.0%
55
 100.0%
164
 100.0%
1.Primary Outcome
Title Change From Baseline in Baseline-adjusted (Montgomery-Asberg Depression Scale) MADRS Score at the End of Treatment.
Hide Description 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.
Time Frame Baseline (start of randomized treatment) and 8 weeks post start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (all subjects of the full analysis set for whom no relevant protocol deviations were documented).
Arm/Group Title ETS6103 (Low Dose) ETS6103 (High Dose) Amitriptyline
Hide Arm/Group Description:

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) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).

ETS6103 (high dose)

Amitriptyline tablets (encapsulated) Standard dosing regime

Amitriptyline

Overall Number of Participants Analyzed 44 43 39
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-6.1396  (1.64423) -6.0076  (1.65174) -11.3762  (1.7344)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ETS6103 (Low Dose) ETS6103 (High Dose) Amitriptyline
Hide Arm/Group Description

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) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).

ETS6103 (high dose)

Amitriptyline tablets (encapsulated) Standard dosing regime

Amitriptyline

All-Cause Mortality
ETS6103 (Low Dose) ETS6103 (High Dose) Amitriptyline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ETS6103 (Low Dose) ETS6103 (High Dose) Amitriptyline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/55 (1.82%)      1/54 (1.85%)      1/55 (1.82%)    
Cardiac disorders       
Myocardial infarction  0/55 (0.00%)  0 1/54 (1.85%)  1 0/55 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis  1/55 (1.82%)  1 0/54 (0.00%)  0 0/55 (0.00%)  0
Psychiatric disorders       
Alcohol abuse  0/55 (0.00%)  0 0/54 (0.00%)  0 1/55 (1.82%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
ETS6103 (Low Dose) ETS6103 (High Dose) Amitriptyline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/55 (78.18%)      50/54 (92.59%)      47/55 (85.45%)    
Cardiac disorders       
Palpitations  2/55 (3.64%)  2 0/54 (0.00%)  0 3/55 (5.45%)  3
Gastrointestinal disorders       
Dry mouth  3/55 (5.45%)  3 7/54 (12.96%)  7 26/55 (47.27%)  26
Vomiting  3/55 (5.45%)  4 6/54 (11.11%)  8 6/55 (10.91%)  6
Nausea  6/55 (10.91%)  6 5/54 (9.26%)  7 0/55 (0.00%)  0
Diarrhoea  1/55 (1.82%)  1 3/54 (5.56%)  3 4/55 (7.27%)  4
Dyspepsia  0/55 (0.00%)  0 2/54 (3.70%)  2 4/55 (7.27%)  4
Constipation  0/55 (0.00%)  0 0/54 (0.00%)  0 5/55 (9.09%)  5
Gastro-oesophageal reflux disease  2/55 (3.64%)  2 1/54 (1.85%)  1 1/55 (1.82%)  1
General disorders       
Fatigue  3/55 (5.45%)  3 7/54 (12.96%)  7 4/55 (7.27%)  4
Infections and infestations       
Upper respiratory tract infection  4/55 (7.27%)  4 5/54 (9.26%)  5 0/55 (0.00%)  0
Investigations       
Electrocardiogram QT prolonged  3/55 (5.45%)  3 1/54 (1.85%)  1 2/55 (3.64%)  2
Blood pressure increased  0/55 (0.00%)  0 1/54 (1.85%)  1 3/55 (5.45%)  3
Mean cell volume  1/55 (1.82%)  1 2/54 (3.70%)  2 1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1/55 (1.82%)  1 2/54 (3.70%)  2 1/55 (1.82%)  1
Nervous system disorders       
Headache  6/55 (10.91%)  6 5/54 (9.26%)  5 3/55 (5.45%)  3
Dizziness  2/55 (3.64%)  2 5/54 (9.26%)  5 4/55 (7.27%)  4
Tremor  0/55 (0.00%)  0 0/54 (0.00%)  0 8/55 (14.55%)  8
Somnolence  0/55 (0.00%)  0 1/54 (1.85%)  1 5/55 (9.09%)  5
Psychiatric disorders       
Abnormal dreams  7/55 (12.73%)  7 8/54 (14.81%)  8 3/55 (5.45%)  3
Anxiety  1/55 (1.82%)  1 1/54 (1.85%)  1 5/55 (9.09%)  5
Nightmare  2/55 (3.64%)  2 4/54 (7.41%)  4 1/55 (1.82%)  1
Irritability  1/55 (1.82%)  1 2/54 (3.70%)  2 1/55 (1.82%)  1
Renal and urinary disorders       
Proteinuria  1/55 (1.82%)  1 1/54 (1.85%)  1 2/55 (3.64%)  2
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  3/55 (5.45%)  3 3/54 (5.56%)  3 2/55 (3.64%)  2
Cough  4/55 (7.27%)  4 1/54 (1.85%)  1 1/55 (1.82%)  1
Skin and subcutaneous tissue disorders       
Pruritus  3/55 (5.45%)  3 7/54 (12.96%)  8 0/55 (0.00%)  0
Hyperhidrosis  4/55 (7.27%)  4 1/54 (1.85%)  1 2/55 (3.64%)  2
Rash  1/55 (1.82%)  1 5/54 (9.26%)  6 0/55 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between 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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Operations Manager
Organization: e-Therapeutics plc
Phone: +44 1993 880000
EMail: contact@etherapeutics.co.uk
Layout table for additonal information
Responsible Party: e-Therapeutics PLC
ClinicalTrials.gov Identifier: NCT02014363     History of Changes
Other Study ID Numbers: ETS6103-003
2013-000719-26 ( EudraCT Number )
First Submitted: December 12, 2013
First Posted: December 18, 2013
Results First Submitted: September 26, 2016
Results First Posted: January 11, 2017
Last Update Posted: January 11, 2017