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

This study has been completed.
Sponsor:
Information provided by:
Community Pharmacology Services Ltd
ClinicalTrials.gov Identifier:
NCT00785434
First received: November 4, 2008
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  Purpose

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:

MedlinePlus related topics: Depression
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785434

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

No publications provided by Community Pharmacology Services Ltd

Additional 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:
MDD
escitalopram

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 23, 2013