AZD7268 Safety and Tolerability Study

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo capsules; Drug: AZD7268; Drug: Escitalopram; Drug: Placebo tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT01020799

D1151C00005

Details and patient eligibility

About

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.

Enrollment: 247 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed, written, and dated Informed Consent prior to any study specific procedures
• Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:
• 296.2x Major Depressive Disorder, Single Episode, or
• 296.3x Major Depressive Disorder, Recurrent

Exclusion criteria

• Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment
• Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
• Patients whose current episode of depression started less than 4 weeks before enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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247 participants in 3 patient groups, including a placebo group

AZD7268

Experimental group

Description:

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.

Treatment:

Drug: AZD7268

Drug: Placebo tablets

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo capsules

Drug: Placebo tablets

Escitalopram

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo capsules

Drug: Escitalopram