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

NCT ID: NCT00785434

Last Updated: 2010-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-12-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active

Active escitalopram

Group Type: EXPERIMENTAL

escitalopram

Intervention Type: DRUG

Dose ranging up to 50mg

Interventions

escitalopram

Dose ranging up to 50mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Community Pharmacology Services Ltd

OTHER

Sponsor Role: lead

Responsible Party

Director, CPS Research

Principal Investigators

Alan G Wade, MBChB

Role: PRINCIPAL_INVESTIGATOR

CPS Research

Locations

CPS Research

Glasgow, , United Kingdom

Countries

United Kingdom

References

Wade AG, Crawford GM, Yellowlees A. Efficacy, safety and tolerability of escitalopram in doses up to 50 mg in Major Depressive Disorder (MDD): an open-label, pilot study. BMC Psychiatry. 2011 Mar 16;11:42. doi: 10.1186/1471-244X-11-42.

Reference Type: DERIVED

PMID: 21410960 (View on PubMed)

Other Identifiers

CPS/04/2008

Identifier Type: -

Identifier Source: org_study_id