EUCTR2008-003359-58-GB
Active, not recruiting
Not Applicable
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
CPS Research0 sites60 target enrollmentJune 18, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- CPS Research
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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