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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00785434
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : January 13, 2010
Sponsor:
Information provided by:
Community Pharmacology Services Ltd

Tracking Information
First Submitted Date  ICMJE November 4, 2008
First Posted Date  ICMJE November 5, 2008
Last Update Posted Date January 13, 2010
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2008)
The number of patients achieving remission (MADRS<9). [ Time Frame: 8 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00785434 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD
Official Title  ICMJE 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: escitalopram
Dose ranging up to 50mg
Study Arms  ICMJE Experimental: Active
Active escitalopram
Intervention: Drug: escitalopram
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00785434
Other Study ID Numbers  ICMJE CPS/04/2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr AG Wade, Director, CPS Research
Study Sponsor  ICMJE Community Pharmacology Services Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alan G Wade, MBChB CPS Research
PRS Account Community Pharmacology Services Ltd
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP