Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder (UNIQUE)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Quetiapine fumarate (Seroquel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00733668

D1449C00009

Details and patient eligibility

About

An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inform consent
• Male and female, age between 18 and 65 years.
• Naïve to any atypical antipsychotic
• A diagnosis of major depressive disorder

Exclusion criteria

• No use of fluvoxamine
• Patients with a history of bipolar I or II disorder
• Diagnosis of psychotic major depression disorder

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)