Conditions: Major Depressive Disorder
Keywords: Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 247
Healthy volunteers: no

Brief summary:
The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.

Detailed description:

Arms:
arm 1: The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only. arm 2: The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only. arm 3: The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only.

Interventions: intervention 1: AZD7268 intervention 2: Escitalopram intervention 3: Placebo capsules intervention 4: Placebo tablets
Intervention descriptions: intervention 1: 15 mg, oral, twice daily (BID) intervention 2: 20 mg, oral, once daily (QD) intervention 3: Placebo capsules to match AZD7268 intervention 4: Placebo tablets to match encapsulated escitalopram

Protocol document: