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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 10 mg Visit 2 - (Week 2) - escitalopram 20 mg Visit 3 - (Week 4) - review visit Visit 4 - (Week 6) - MADRS <12 - continue 20 mg MADRS >12 - escitalopram 30 mg Visit 5 - (Week 8) - MADRS <8 - continue current dose MADRS >8 - escalate dose (20 mg to 30 mg or 30 mg to 35mg) Thereafter, Patients who have achieved remission will be maintained on the remission dosage and reviewed at four weekly intervals. At any subsequent visit where the MADRS is >8 they will have a dosage increase Patients who have not achieved remission will have dosage escalated by 5 mg at two weekly intervals until remission, a maximum dose of 50 mg is achieved or the dosage is intolerable when they will be reduced to the previous tolerable dose. Patients will be followed up until eight months from their initial visit.

Official Title
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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).

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: escitalopram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Active escitalopram | Drug: escitalopram<br>* Dose ranging up to 50mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients achieving remission (MADRS<9). |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDD, escitalopram