Unipolar DepressionPhase 2/3ESPIONNCT01219686
EScitalopram PIndolol ONset of Action
A Phase 2/3 study testing escitalopram, pindolol and escitalopram in people with Unipolar Depression, run by Markus KOSEL at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- escitalopram, pindolol and escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2010to Jun 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre de Thérapies Breves (CTB), Secteur Jonction
Geneva, 1205
About this study
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
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.
Read the 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
- Being tested
- escitalopram, pindolol, escitalopram
- Keywords
- unipolar depression, escitalopram, pindolol
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopram, pindololDrug
Also called escitalopram/Cipralex, pindolol/Viskene
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
escitalopramDrug
escitalopram p.o., once daily. days 1-2: 10 mg, days 3-4: 20 mg, days 5-42: 30 mg
escitalopramDrug
escitalopram 20 mg, p.o., once daily. Days 1-2: 10mg, days 3-42: 20 mg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: escitalopram |
| escitalopram 20 mg | Active comparator | days 1-2: escitalopram 10 mg+ placebo, days 3-42: escitalopram 20 mg + placebo Receives: Drug: escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS score change between baseline and 2 weeks of treatment
Differences in MADRS score changes (baseline-day 14) between treatment groups
Measured: day 14
Secondary outcomes (3)
Response/remission (MADRS) at 6 weeks
% of patients with a given treatment which meet response/remssion criteria after 6 weeks of treatment, based on MADRS
Measured: day 42
Adverse events
Frequence of adverse events in treatment groups
Measured: See primary outcome measure
Correlation of drug level of pindolol and/or escitalopram and clinical outcome (primary outcome) between treatment groups
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2013
- Study completionJun 2013
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Markus KOSEL
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, University of Lausanne Hospitals, University Hospital, Basel, Switzerland, H. Lundbeck A/S
- Responsible party
- Sponsor-investigator, Markus KOSEL, University Hospital, Geneva
- Investigators
- Markus Kosel, MD-PhD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219686
- Sponsor's protocol ID
- CER 09-054, Psy 09-004
- Acronym
- ESPION
- Status last verified
- May 2015
- First submitted
- 7 Oct 2010
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01219686
- Acronym / sponsor ID
- ESPION / CER 09-054, Psy 09-004
- Conditions
- Unipolar Depression
- Keywords
- unipolar depression, escitalopram, pindolol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Markus KOSELUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, University of Lausanne Hospitals, University Hospital, Basel, Switzerland, H. Lundbeck A/S
- Study start
- Oct 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| escitalopram 20mg + pindolol 15mg | Experimental | Drug: escitalopram, pindololDays 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 mg | Active comparator | Drug: escitalopramDays 1-2: escitalopram 10 mg+ placebo, days 3-4 escitalopram 20 mg + placebo, days 5-42: escitalopram 30mg+ placebo |
| escitalopram 20 mg | Active comparator | Drug: escitalopramdays 1-2: escitalopram 10 mg+ placebo, days 3-42: escitalopram 20 mg + placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopram, pindololAlso: escitalopram/Cipralex, pindolol/Viskeneescitalopram 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 | escitalopram 20mg + pindolol 15mg |
| escitalopramescitalopram p.o., once daily. days 1-2: 10 mg, days 3-4: 20 mg, days 5-42: 30 mg | Drug | Escitalopram 30 mg |
| escitalopramescitalopram 20 mg, p.o., once daily. Days 1-2: 10mg, days 3-42: 20 mg | Drug | escitalopram 20 mg |
Primary outcome
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
3 secondary outcomes
Response/remission (MADRS) at 6 weeks
Time frame: day 42
Adverse events
Time frame: See primary outcome measure
Correlation of drug level of pindolol and/or escitalopram and clinical outcome (primary outcome) between treatment groups
Time frame: Day 10
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Kosel, MD-PhD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing escitalopram, pindolol and escitalopram in people with Unipolar Depression, run by Markus KOSEL at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS score change between baseline and 2 weeks of treatment (time frame: day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.