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

Community Pharmacology Services Ltd

Status and phase

Completed

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: escitalopram

Study type

Interventional

Funder types

Other

Identifiers

NCT00785434

CPS/04/2008

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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