Major Depressive Disorder MedDRA version: 9.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS
Conditions
Interventions
Trade Name: Cipralex 5mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ESCITALOPRAM
Concentration unit: mg milligram(s)
Concentration type: equal
CAS Number: 219861082
Other descriptive name
Sponsors
CPS Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed