EScitalopram PIndolol ONset of Action
Information source: University Hospital, Geneva
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unipolar Depression
Intervention: escitalopram, pindolol (Drug); escitalopram (Drug); escitalopram (Drug)
Phase: Phase 2/Phase 3
Status: Terminated
Sponsored by: Markus KOSEL Official(s) and/or principal investigator(s): Markus Kosel, MD-PhD, Principal Investigator, Affiliation: University Hospital, Geneva
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: MADRS score change between baseline and 2 weeks of treatment
Secondary outcome: Response/remission (MADRS) at 6 weeksAdverse events Correlation of drug level of pindolol and/or escitalopram and clinical outcome (primary outcome) between treatment groups
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Centre de Thérapies Breves (CTB), Secteur Jonction, Geneva 1205, Switzerland
Additional Information
Starting date: October 2010
Last updated: May 26, 2015
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