AZD6765 Severe Major Depressive Disorder (MDD) IV

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: AZD6765

Study type: Interventional

Funder types: Industry

Identifiers

NCT00781742

D6702C00009

Details and patient eligibility

About

The purpose of this research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression medication in the blood. In addition, the research staff will determine if AZD6765 has any mood or calming effects (how you feel).

Enrollment: 152 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent before any study-related procedures start.
• The patient is previously diagnosed with Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.
• Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for ≥4 weeks.

Exclusion criteria

• Patient has a lifetime history of schizophrenia, bipolar, psychosis or psychotic depression.
• Patient has a lifetime history of failure to ECT therapy.
• Patient is pregnant or breast feeding.
• Length of current episode of depression exceeds ≥2 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

152 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

100 mg iv once per dosing day

Treatment:

Drug: AZD6765

2

Experimental group

Description:

150 mg iv once per dosing day

Treatment:

Drug: AZD6765

3

Placebo Comparator group

Treatment:

Drug: Placebo