Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be an open label study of escitalopram. Patients not responsive to citalopram will be switched directly to escitalopram.

Patients will receive escalating doses of escitalopram up to a maximum of 50 mg until they either achieve remission (MADRS <9) or fail to tolerate the dose.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Community Pharmacology Services Ltd
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• written informed consent will be obtained from each patient

• aged 18 to 65 inc

• suffering from MDD as defined by DSM IV

• have been taking citalopram in a dose of at least 20mg for at least six weeks

• an inadequate response -- defined as failure to achieve a MADRS score of <12

Exclusion Criteria:

• 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 .

• history of mania or bipolar disorder

• Known contraindication for the use of citalopram or escitalopram.

• Significant bleeding disorder

• Prominent suicidal ideation (score more than 4 in the MADRS "suicidal thoughts" item)

• Alcohol or substance dependence in the past 6 months

• Major physical illness

• Significant liver or renal function abnormality

• Significant ECG abnormalities

• Pregnant or lactating females

• Inadequate contraception