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

This study has been completed.
Information provided by:
Community Pharmacology Services Ltd
ClinicalTrials.gov Identifier:
First received: November 4, 2008
Last updated: January 12, 2010
Last verified: January 2010

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.

Condition Intervention Phase
Major Depressive Disorder
Drug: escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:

Further study details as provided by Community Pharmacology Services Ltd:

Primary Outcome Measures:
  • The number of patients achieving remission (MADRS<9). [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Active escitalopram
Drug: escitalopram
Dose ranging up to 50mg

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785434

United Kingdom
CPS Research
Glasgow, United Kingdom, G20 0XA
Sponsors and Collaborators
Community Pharmacology Services Ltd
Principal Investigator: Alan G Wade, MBChB CPS Research
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr AG Wade, Director, CPS Research
ClinicalTrials.gov Identifier: NCT00785434     History of Changes
Other Study ID Numbers: CPS/04/2008 
Study First Received: November 4, 2008
Last Updated: January 12, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Community Pharmacology Services Ltd:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on May 23, 2016