Status:
COMPLETED
Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD
Lead Sponsor:
Community Pharmacology Services Ltd
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 maxim...
Detailed Description
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. Visit 1 - (Initial visit) - escitalopram ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00785434
Start Date
October 1 2008
End Date
December 1 2009
Last Update
January 13 2010
Active Locations (1)
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1
CPS Research
Glasgow, United Kingdom, G20 0XA