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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2009

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.

Intervention(s) in this Clinical Trial

• Drug: escitalopram
  • Dose ranging up to 50mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Active
  • Active escitalopram

Primary Measures

• The number of patients achieving remission (MADRS<9).
  • Time Frame: 8 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Community Pharmacology Services Ltd

Overall Clinical Trial Officials and Contacts

Alan G Wade, MBChB Principal Investigator CPS Research  

Overall Contact: Alan G Wade, MBChB +44 (0)141 946 7888 alan@cpsresearch.co.uk

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00785434

Study ID Number: CPS/04/2008

ClinicalTrials.gov Identifier: NCT00785434

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency