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EScitalopram PIndolol ONset of Action (ESPION)

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: NCT01219686
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : October 13, 2010
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
University Hospital, Geneva
University of Lausanne Hospitals
University Hospital, Basel, Switzerland
H. Lundbeck A/S
Information provided by (Responsible Party):
Markus KOSEL, University Hospital, Geneva

Tracking Information
First Submitted Date  ICMJE October 7, 2010
First Posted Date  ICMJE October 13, 2010
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
MADRS score change between baseline and 2 weeks of treatment [ Time Frame: day 14 ]
Differences in MADRS score changes (baseline-day 14) between treatment groups
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01219686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
  • Response/remission (MADRS) at 6 weeks [ Time Frame: day 42 ]
    % of patients with a given treatment which meet response/remssion criteria after 6 weeks of treatment, based on MADRS
  • Adverse events [ Time Frame: See primary outcome measure ]
    Frequence of adverse events in treatment groups
  • Correlation of drug level of pindolol and/or escitalopram and clinical outcome (primary outcome) between treatment groups [ Time Frame: Day 10 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EScitalopram PIndolol ONset of Action
Official Title  ICMJE Antidepressant Effect of Escitalopram: Delay of Onset. Clinical Randomized Double-blinded Study With Three Parallel Treatment Groups (Escitalopram 20mg vs Escitalopram 30mg vs Escitalopram 20 mg + Pindolol 15 mg/Day
Brief Summary The main purpose of this study is to determine whether the antidepressant response of escitalopram 30mg/day or escitalopram 20mg/day + pindolol, a beta blocker, is different (faster) compared to a standard dose of escitalopram 20mg/day.
Detailed Description

Antidepressant drug therapy is the primary therapeutic treatment option in moderate to severe Major Depressive Disorder. However, clinically significant antidepressant response needs sustained treatment during weeks to months. Indeed, in the largest effectiveness study conducted to date (STAR*D study) involving nearly 3000 depressed outpatients, only about one third of those who ultimately responded did so after 6 weeks of drug treatment and for most patients longer treatment periods were necessary. This delay implies prolonged suffering for the patients and their families. By its antagonist action on the serotonin 1A receptor pindolol is hypothesized to reduce the down-regulation mechanisms of antidepressants. It is therefore expected that addition of pindolol to escitalopram will shorten the therapeutic response. Clinical and preclinical data indicate that escitalopram at 30 mg/day might be more effective and perhaps be associated with a faster onset of action than 20mg. For this purpose the speed of action will be compared between three blindly randomized samples:

  • escitalopram 20mg per day + placebo
  • escitalopram 30mg per day + placebo
  • escitalopram 20mg per day + pindolol 15mg per day (two doses of 7.5mg during 14 days).

Subjects will be followed for 6 weeks. The dose of 15mg pindolol per day (during 14 days) is based on the optimal occupancy of the serotonin 1A receptor.

At inclusion all subjects will be assessed by a trained psychiatrist using the SCID I mood disorder part which is based on DSM IV criteria, and by means of the French version of the MINI. Severity of depression will be assessed using the MADRS clinician rated and self-report questionnaire, and the French version of the QIDS.

Each week subjects will be assessed using the two versions of the Montgomery-Asberg Depression Rating Scale (MADRS) and the HCL-32 a self-report questionnaire assessing hypomania.

It is planned to include 135 patients during the three years of the study duration resulting in 45 subjects in each group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Unipolar Depression
Intervention  ICMJE
  • Drug: escitalopram, pindolol
    escitalopram p.o., once daily, day 1-2: 10mg, days 3-42: 20mg pindolol p.o., twice daily 7.5 mg days 1-14, once daily 7.5 mg days 15-17
    Other Names:
    • escitalopram/Cipralex
    • pindolol/Viskene
  • Drug: escitalopram
    escitalopram p.o., once daily. days 1-2: 10 mg, days 3-4: 20 mg, days 5-42: 30 mg
  • Drug: escitalopram
    escitalopram 20 mg, p.o., once daily. Days 1-2: 10mg, days 3-42: 20 mg
Study Arms  ICMJE
  • Experimental: escitalopram 20mg + pindolol 15mg
    Days 1-2: escitalopram 10 mg + placebo, days 3-42: escitalopram 20mg + placebo Days 1-14: pindolol 15 mg, days 15-17: pindolol 7.5 mg
    Intervention: Drug: escitalopram, pindolol
  • Active Comparator: Escitalopram 30 mg
    Days 1-2: escitalopram 10 mg+ placebo, days 3-4 escitalopram 20 mg + placebo, days 5-42: escitalopram 30mg+ placebo
    Intervention: Drug: escitalopram
  • Active Comparator: escitalopram 20 mg
    days 1-2: escitalopram 10 mg+ placebo, days 3-42: escitalopram 20 mg + placebo
    Intervention: Drug: escitalopram
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 26, 2015)
18
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2010)
135
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients aged between 18 and 65 years old
  • patients suffering from major depression according to DSM-IV with a MADRS score of at least 25 and not treated by an antidepressant at the time of inclusion with the exception of non-responders to antidepressant for a period of at least 6 weeks or not tolerating an ongoing antidepressant necessitating a change of the antidepressant(excluding fluoxetine and irreversible MAOI)
  • informed consent

Exclusion criteria:

  • any other Axis I disorder excluding anxiety disorder not dominating the clinical picture, nicotine abuse
  • non-responders to escitalopram in the past
  • already taking pindolol
  • pregnancy and breast feeding
  • contraindication to one of the two treatments (medical conditions, drug treatments)
  • significant somatic comorbidity interfering with the study procedures
  • high risk of suicidality
  • women of childbearing age not having a safe means of 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 Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01219686
Other Study ID Numbers  ICMJE CER 09-054, Psy 09-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Markus KOSEL, University Hospital, Geneva
Study Sponsor  ICMJE Markus KOSEL
Collaborators  ICMJE
  • University Hospital, Geneva
  • University of Lausanne Hospitals
  • University Hospital, Basel, Switzerland
  • H. Lundbeck A/S
Investigators  ICMJE
Principal Investigator: Markus Kosel, MD-PhD University Hospital, Geneva
PRS Account University Hospital, Geneva
Verification Date May 2015

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