Unipolar Depression | EScitalopram PIndolol ONset of Action
Unipolar Depression research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:escitalopram, pindololescitalopram 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
Drug:escitalopramescitalopram p.o., once daily. days 1-2: 10 mg, days 3-4: 20 mg, days 5-42: 30 mg
Drug:escitalopramescitalopram 20 mg, p.o., once daily. Days 1-2: 10mg, days 3-42: 20 mg
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
escitalopram 20mg + pindolol 15mgDays 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
Escitalopram 30 mgDays 1-2: escitalopram 10 mg+ placebo, days 3-4 escitalopram 20 mg + placebo, days 5-42: escitalopram 30mg+ placebo
escitalopram 20 mgdays 1-2: escitalopram 10 mg+ placebo, days 3-42: escitalopram 20 mg + placebo
Start Date: October 2010
Completed Date: June 2013
Phase: Phase 2/Phase 3
Primary Outcome: MADRS score change between baseline and 2 weeks of treatment
Secondary Outcome: Response/remission (MADRS) at 6 weeks
Study sponsors, principal investigator, and references
Principal Investigator: Markus Kosel, MD-PhD
Lead Sponsor: Markus KOSEL
Collaborator: University Hospital, Geneva