NCT00785434

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

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).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Community Pharmacology Services Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	escitalopram	Dose ranging up to 50mg

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-11-05
• Last updated: 2010-01-13

Locations

1 site across 1 country: United Kingdom