Major Depressive Disorder Clinical Trial
Official title:
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).
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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