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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. Identifier: NCT01219686
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : October 13, 2010
Last Update Posted : May 27, 2015
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

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.

Condition or disease Intervention/treatment Phase
Unipolar Depression Drug: escitalopram, pindolol Drug: escitalopram Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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

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
Drug: escitalopram
escitalopram p.o., once daily. days 1-2: 10 mg, days 3-4: 20 mg, days 5-42: 30 mg

Active Comparator: escitalopram 20 mg
days 1-2: escitalopram 10 mg+ placebo, days 3-42: escitalopram 20 mg + placebo
Drug: escitalopram
escitalopram 20 mg, p.o., once daily. Days 1-2: 10mg, days 3-42: 20 mg

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. Adverse events [ Time Frame: See primary outcome measure ]
    Frequence of adverse events in treatment groups

  3. Correlation of drug level of pindolol and/or escitalopram and clinical outcome (primary outcome) between treatment groups [ Time Frame: Day 10 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01219686

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Centre de Thérapies Breves (CTB), Secteur Jonction
Geneva, Switzerland, 1205
Sponsors and Collaborators
Markus KOSEL
University Hospital, Geneva
University of Lausanne Hospitals
University Hospital, Basel, Switzerland
H. Lundbeck A/S
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Principal Investigator: Markus Kosel, MD-PhD University Hospital, Geneva
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Responsible Party: Markus KOSEL, MD-PhD, University Hospital, Geneva Identifier: NCT01219686    
Other Study ID Numbers: CER 09-054, Psy 09-004
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Markus KOSEL, University Hospital, Geneva:
unipolar depression, escitalopram, pindolol
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antihypertensive Agents