This is a Study to Determine the Antidepressant Effects of AZD6765

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Treatment Resistant Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZD6765 (150 mg) / Placebo

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.

Group Type EXPERIMENTAL

AZD6765

Intervention Type DRUG

Single IV infusion of 150 mg AZD6765.

Placebo / AZD6765 (150 mg)

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.

Group Type PLACEBO_COMPARATOR

Placebo to AZD6765

Intervention Type DRUG

Single IV infusion of Placebo to AZD6765

Interventions

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AZD6765

Single IV infusion of 150 mg AZD6765.

Intervention Type DRUG

Placebo to AZD6765

Single IV infusion of Placebo to AZD6765

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No