Conditions: Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 164
Healthy volunteers: no

Brief summary:
To demonstrate that the antidepressant activity of ETS6103 is not inferior to amitriptyline in subjects who have an unsatisfactory response to / are resistant to treatment with SSRIs.

Detailed description:

Arms:
arm 1: ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks). arm 2: ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks). arm 3: Amitriptyline tablets (encapsulated) Standard dosing regime arm 4: Citalopram tablets:

Standard dosing regime

Interventions: intervention 1: ETS6103 (low dose) intervention 2: ETS6103 (high dose) intervention 3: Amitriptyline
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: