EScitalopram PIndolol ONset of Action

NCT01219686 | Terminated Phase 2 DMC

• 1 other identifier: CER 09-054, Psy 09-004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Unipolar Depression

Keywords

unipolar depression, escitalopram, pindolol

Outcome Measures

Primary Outcomes (1)

• MADRS score change between baseline and 2 weeks of treatment

  Differences in MADRS score changes (baseline-day 14) between treatment groups

  day 14

Secondary Outcomes (3)

• Response/remission (MADRS) at 6 weeks

  day 42

• Adverse events

  See primary outcome measure

• Correlation of drug level of pindolol and/or escitalopram and clinical outcome (primary outcome) between treatment groups

  Day 10

Study Arms (3)

escitalopram 20mg + pindolol 15mg

EXPERIMENTAL

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 30 mg

ACTIVE COMPARATOR

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

Drug: escitalopram

escitalopram 20 mg

ACTIVE COMPARATOR

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

Drug: escitalopram

Interventions

escitalopram, pindolol 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

Also known as: escitalopram/Cipralex, pindolol/Viskene

escitalopram 20mg + pindolol 15mg

escitalopram DRUG

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

Escitalopram 30 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged between 18 and 65 years old
• informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Markus KOSEL: lead
• University Hospital, Geneva: collaborator
• University of Lausanne Hospitals: collaborator
• University Hospital, Basel, Switzerland: collaborator
• H. Lundbeck A/S: collaborator

Study Sites (1)

Centre de Thérapies Breves (CTB), Secteur Jonction

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Depressive Disorder

Interventions

Escitalopram; Pindolol; Dexetimide

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Markus Kosel, MD-PhD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD-PhD

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 13, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

CH (1)