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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
escitalopram
Sponsored by
Community Pharmacology Services Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, escitalopram

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CPS Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

Active escitalopram

Outcomes

Primary Outcome Measures

The number of patients achieving remission (MADRS<9).

Secondary Outcome Measures

Full Information

First Posted
November 4, 2008
Last Updated
January 12, 2010
Sponsor
Community Pharmacology Services Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00785434
Brief Title
Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD
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).
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Community Pharmacology Services Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD, escitalopram

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Active escitalopram
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Description
Dose ranging up to 50mg
Primary Outcome Measure Information:
Title
The number of patients achieving remission (MADRS<9).
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan G Wade, MBChB
Organizational Affiliation
CPS Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
CPS Research
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21410960
Citation
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.
Results Reference
derived

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

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