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

AstraZeneca

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Major Depressive Disorder

Interventions

Quetiapine fumarate (Seroquel)DRUG

300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

Research Site

Bruges, Belgium

Research Site

Leuven, Belgium

Research Site

Liège, Belgium

Research Site

Sint-Truiden, Belgium

Outcomes

Primary Outcomes

The Montgomery-Asberg Depression Scale (MADRS) score

Time frame: Visit 1 - > 5

Secondary Outcomes

The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)

Time frame: Visit 1 - > 5 (1 week between each visit)

Sheehan Disability Scale (SDS) score

Time frame: Visit 1 - > 5 (1 week between each visit)

The Symptom Checklist 90 Revisred (SCL-90-R) score

Time frame: Visit 1 - > 5 (1 week between each visit)

Data from ClinicalTrials.gov

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