Major Depressive Disorder Clinical Trial
Official title:
Phase IV 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).
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | CPS Research | Glasgow |
Lead Sponsor | Collaborator |
---|---|
Community Pharmacology Services Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of patients achieving remission (MADRS<9). | 8 months | Yes |
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