EScitalopram PIndolol ONset of Action

NCT ID: NCT01219686

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-06-30

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.

Conditions

Unipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

escitalopram, pindolol

Intervention Type: DRUG

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

Escitalopram 30 mg

Days 1-2: escitalopram 10 mg+ placebo, days 3-4 escitalopram 20 mg + placebo, days 5-42: escitalopram 30mg+ placebo

Group Type: ACTIVE_COMPARATOR

escitalopram

Intervention Type: DRUG

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

escitalopram 20 mg

days 1-2: escitalopram 10 mg+ placebo, days 3-42: escitalopram 20 mg + placebo

Group Type: ACTIVE_COMPARATOR

escitalopram

Intervention Type: DRUG

escitalopram 20 mg, p.o., once daily. Days 1-2: 10mg, days 3-42: 20 mg

Interventions

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

Intervention Type: DRUG

escitalopram

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

Intervention Type: DRUG

escitalopram

escitalopram 20 mg, p.o., once daily. Days 1-2: 10mg, days 3-42: 20 mg

Intervention Type: DRUG

Other Intervention Names

escitalopram/Cipralex; pindolol/Viskene

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Markus KOSEL

OTHER

Sponsor Role: lead

Responsible Party

Markus KOSEL

MD-PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Markus Kosel, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Centre de Thérapies Breves (CTB), Secteur Jonction

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

CER 09-054, Psy 09-004

Identifier Type: -

Identifier Source: org_study_id