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

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: escitalopram

• Registration Number: NCT00785434
• Lead Sponsor: Community Pharmacology Services Ltd

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 maximum of 50 mg until they either achieve remission (MADRS \<9) or fail to tolerate the dose.

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 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	escitalopram	Active escitalopram

Primary Outcome Measures

Name	Time	Method
The number of patients achieving remission (MADRS<9).	8 months

Trial Locations

Locations (1)

CPS Research; 🇬🇧 Glasgow, United Kingdom