Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD
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).
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 major-depressive-disorder
Started Oct 2008
Shorter than P25 for phase_4 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 4, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJanuary 13, 2010
January 1, 2010
1.2 years
November 4, 2008
January 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of patients achieving remission (MADRS<9).
8 months
Study Arms (1)
Active
EXPERIMENTALActive escitalopram
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CPS Research
Glasgow, G20 0XA, United Kingdom
Related Publications (1)
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.
PMID: 21410960DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan G Wade, MBChB
CPS Research
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 4, 2008
First Posted
November 5, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
January 13, 2010
Record last verified: 2010-01