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

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785434
• Other study ID #: CPS/04/2008
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2008
• Last updated: January 12, 2010
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Community Pharmacology Services Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• escitalopram
Dose ranging up to 50mg

Locations

Country	Name	City	State
United Kingdom	CPS Research	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Community Pharmacology Services Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients achieving remission (MADRS<9).		8 months	Yes