A pilot study to examine the efficacy and safety of escitalopram in doses up to 50 mg for the treatment of patients with Major Depressive Disorder (MDD). - Resistant Depression Study

• Conditions: Major Depressive Disorder; MedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOS

• Registration Number: EUCTR2008-003359-58-GB
• Lead Sponsor: CPS Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.written informed consent will be obtained from each patient
2.aged 18 to 65 inc
3.suffering from MDD as defined by DSM IV
4.have been taking citalopram in a dose of at least 20mg for at least six weeks
5.an inadequate response -- defined as failure to achieve a MADRS score of <12
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Significant other psychiatric disorder which would interfere with trial assessments. Co-morbid generalized anxiety disorder (GAD) and panic will be permitted where MDD is considered the primary diagnosis .
2.history of mania or bipolar disorder
3.Known contraindication for the use of citalopram or escitalopram.
4.Significant bleeding disorder
5.Prominent suicidal ideation (score more than 4 in the MADRS suicidal thoughts” item)
6.Alcohol or substance dependence in the past 6 months
7.Major physical illness
8.Significant liver or renal function abnormality
9.Significant ECG abnormalities
10.Pregnant or lactating females
11.Inadequate contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This is a pilot study designed to produce information on the tolerability, efficacy and safety of higher doses of escitalopram in the treatment of Major Depressive Disorder (MDD).;Secondary Objective: Not applicable;Primary end point(s): This will be a pilot study designed to provide limited information on safety and tolerability of escitalopram in doses up to 50mg.