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
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: ETS6103 (low dose) Drug: ETS6103 (high dose) Drug: Amitriptyline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double Blind, Non-inferiority Study to Evaluate the Antidepressant Activity of ETS6103 Compared to Amitriptyline in Treating Major Depressive Disorder in Patients With Unsatisfactory Response to Selective Serotonin Re-uptake Inhibitors.|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: 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).
Drug: ETS6103 (low dose)
Experimental: 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).
Drug: ETS6103 (high dose)
Active Comparator: Amitriptyline
Amitriptyline tablets (encapsulated) Standard dosing regime
No Intervention: Lead-in phase
Standard dosing regime
- Change From Baseline in Baseline-adjusted (Montgomery-Asberg Depression Scale) MADRS Score at the End of Treatment. [ Time Frame: Baseline (start of randomized treatment) and 8 weeks post start of treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014363
|Glasgow, Scotland, United Kingdom, G20 OXA|
|Principal Investigator:||Alan G Wade, MBChb||CPS Research|