This is a Study to Determine the Antidepressant Effects of AZD6765

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Treatment Resistant Major Depressive Disorder

Treatments: Drug: Placebo to AZD6765; Drug: AZD6765

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00986479

D6702C00015

Details and patient eligibility

About

The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of Major Depressive Disorder, currently depressed without psychotic features
• Females must be of non-childbearing potential.

Exclusion criteria

• Treatment with Clozapine or ECT within 3 months prior to study
• Current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

AZD6765 (150 mg) / Placebo

Experimental group

Description:

Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.

Treatment:

Drug: AZD6765

Placebo / AZD6765 (150 mg)

Placebo Comparator group

Description:

Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.

Treatment:

Drug: Placebo to AZD6765