Major Depressive DisorderNCT02480400
The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment Depression
A study testing Escitalopram in people with Major Depressive Disorder, run by Abarbanel Mental Health Center at 1 site in Israel.
Trial summary
To evaluate the effect of visit number, patient expectation, and rater expectation of the efficacy of escitalopram treatment in fixed doses of 10 and 20mg, based on baseline severity in patients with MDD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Oct 2012
- Phase
- Interventional
- 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
- Outpatients, men and women between 18 and 65 years of age (both extremes included)
- DSM IV-TR criteria for a current MDE lasting between 3 and 12 months
- Baseline MADRS total score > 22
Who cannot join
- WHO-5 total score > 13 or a score > 3 on any single item of the WHO-5 (not revealed to the investigator)
- Other primary or co-primary psychiatric disorder which is more distressful for the patient than MDDD, as evaluated by investigator
- Patients with any history of mania/bipolar I disorder
- Patients using medications which are contraindicated with the use of escitalopram
- Known contraindication for the use of citalopram or escitalopram
- Patients that have not responded to 2 or more treatments with an adequate dose of an antidepressant for an adequate time
Show all 10Show fewer
- Patients receiving formal behaviour therapy, or systematic psychotherapy
- Unable to understand or read Hebrew and give written informed consent
- Prominent suicidal ideation > 5 on item 10 (suicidal thoughts) of the MADRS]
- Alcohol or substance dependence in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment of Patients With Major Depressive Disorder.
To evaluate the effect of visit number, patient expectation, and rater expectation of the efficacy of escitalopram treatment in fixed doses of 10 and 20mg, based on baseline severity in patients with MDD.
Read the detailed description
This study is designed to determined if trial design, in the form of the frequency of patient contact (assessment visit numbers) has an effect on the efficacy outcome after 8-week treatment with escitalopram.
The placebo response is a major issue in clinical trials for psychiatric disorders-and especially in the management of depression. Possible contributing factors to this problem include diagnostic misclassification, issues concerning inclusion/exclusion criteria, outcome measures' lack of sensitivity to change, measurement errors, poor quality of data entry and verification, waxing and waning of the natural course of depression, regression toward the mean phenomenon, patient and clinician expectations about the trial, study design issues, non-specific therapeutic effects, and high attrition.
Over the past few decades, researchers have attempted to reduce the placebo effect in a variety of ways. Unfortunately, approaches with very little or no benefit have included restricting enrollment to selected populations, rater training, requirement of same rater, and placebo lead-in phases. Some benefits, although often marginal, have been derived from standardizing diagnostic procedures, managing clinicians' overestimation of change, simplification of study visits and assessments, minimizing nonspecific, therapeutic effects, extending trial duration, reducing number of sites, increasing the sensitivity of outcome measures, and reducing the number of treatment arms.
Thus far, there has been no attempt to develop new study designs aimed at reducing the placebo effect.
We are proposing a novel study design, suitable for doubleblind, trials in mood disorders. This design is aimed at characterizing and identifying both the overall placebo response rate and the sample size required for such
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram
- Keywords
- MDD, Escitalopram, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Cipralex, Lexapro
Patients diagnosed with MDD and will fulfill the inclusion and exclusion criteria will start with escitalopram 10mg, according to the Summary of Product Characteristics. At week 2, patients with a baseline MADRS between 22 and 29 continue on 10mg, and patients with a baseline MADRS > 30 receive a fixed dose 20mg until the end of treatment.
EscitalopramDrug
Also called Cipralex, Lexapro
Patients diagnosed with MDD and will fulfill the inclusion and exclusion criteria will start with escitalopram 10mg, according to the Summary of Product Characteristics. At week 2, patients with a baseline MADRS between 22 and 29 continue on 10mg, and patients with a baseline MADRS > 30 receive a fixed dose 20mg until the end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Supported Escitalopram | Experimental | Escitalopram, with assessment visits at baseline, and weeks 2, 4, 6 and 8 Receives: Drug: Escitalopram |
| Escitalopram | Active comparator | Escitalopram, with assessment visits at baseline, week 4 and week 8, and a safety visit at week 2 Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sheehan Disability Scale
The Sheehan Disability Scale (Sheehan 1983) is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by panic, anxiety, phobic, or depressive symptoms. This scale has been used widely in psychopharmacology randomized controlled trials, particularly for panic disorder. This anchored visual analog scale uses spatiovisual, numeric, and verbal descriptive anchors simultaneously to assess disability across three domains: work, social life, and family life.
Measured: Change from baseline to study completion by week 8.
Secondary outcomes (1)
Montgomery Åsberg Depression Rating Scale
This is a 10-item checklist. Widely used in drug-treatment trials, mainly because of its particular sensitivity to treatment effects. Since there is a comparative lack of emphasis on somatic symptoms, the scale is useful for the assessment of depression in people with physical illness.
Measured: Change from baseline to study completion in week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abarbanel Mental Health Center
- Sponsor type
- Other government
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Principal investigator, Yoram Barak, Abarbanel Mental Health Center
- Investigators
- Yehuda Baruch, MD, MHA, Study chair, Abarbanel MHC, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480400
- Sponsor's protocol ID
- Lu-Pl-001
- Status last verified
- Jun 2015
- First submitted
- 22 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gomeni R, Lavergne A, Merlo-Pich E. Modelling placebo response in depression trials using a longitudinal model with informative dropout. Eur J Pharm Sci. 2009 Jan 31;36(1):4-10. doi: 10.1016/j.ejps.2008.10.025. Epub 2008 Nov 8.
PubMed 19041717
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment of Patients With Major Depressive Disorder.
- ClinicalTrials.gov ID
- NCT02480400
- Acronym / sponsor ID
- Lu-Pl-001
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Escitalopram, Placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Abarbanel Mental Health CenterOther government
- Collaborators
- H. Lundbeck A/S
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Jun 2015 (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.
To evaluate the effect of visit number, patient expectation, and rater expectation of the efficacy of escitalopram treatment in fixed doses of 10 and 20mg, based on baseline severity in patients with MDD.
Detailed description
This study is designed to determined if trial design, in the form of the frequency of patient contact (assessment visit numbers) has an effect on the efficacy outcome after 8-week treatment with escitalopram.
The placebo response is a major issue in clinical trials for psychiatric disorders-and especially in the management of depression. Possible contributing factors to this problem include diagnostic misclassification, issues concerning inclusion/exclusion criteria, outcome measures' lack of sensitivity to change, measurement errors, poor quality of data entry and verification, waxing and waning of the natural course of depression, regression toward the mean phenomenon, patient and clinician expectations about the trial, study design issues, non-specific therapeutic effects, and high attrition.
Over the past few decades, researchers have attempted to reduce the placebo effect in a variety of ways. Unfortunately, approaches with very little or no benefit have included restricting enrollment to selected populations, rater training, requirement of same rater, and placebo lead-in phases. Some benefits, although often marginal, have been derived from standardizing diagnostic procedures, managing clinicians' overestimation of change, simplification of study visits and assessments, minimizing nonspecific, therapeutic effects, extending trial duration, reducing number of sites, increasing the sensitivity of outcome measures, and reducing the number of treatment arms.
Thus far, there has been no attempt to develop new study designs aimed at reducing the placebo effect.
We are proposing a novel study design, suitable for doubleblind, trials in mood disorders. This design is aimed at characterizing and identifying both the overall placebo response rate and the sample size required for such
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supported Escitalopram | Experimental | Drug: EscitalopramEscitalopram, with assessment visits at baseline, and weeks 2, 4, 6 and 8 |
| Escitalopram | Active comparator | Drug: EscitalopramEscitalopram, with assessment visits at baseline, week 4 and week 8, and a safety visit at week 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients, men and women between 18 and 65 years of age (both extremes included)
- DSM IV-TR criteria for a current MDE lasting between 3 and 12 months
- Baseline MADRS total score > 22
Key exclusion criteria (10 listed)
- WHO-5 total score > 13 or a score > 3 on any single item of the WHO-5 (not revealed to the investigator)
- Other primary or co-primary psychiatric disorder which is more distressful for the patient than MDDD, as evaluated by investigator
- Patients with any history of mania/bipolar I disorder
- Patients using medications which are contraindicated with the use of escitalopram
- Known contraindication for the use of citalopram or escitalopram
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 |
|---|---|---|
| EscitalopramAlso: Cipralex, LexaproPatients diagnosed with MDD and will fulfill the inclusion and exclusion criteria will start with escitalopram 10mg, according to the Summary of Product Characteristics. At week 2, patients with a baseline MADRS between 22 and 29 continue on 10mg, and patients with a baseline MADRS > 30 receive a fixed dose 20mg until the end of treatment. | Drug | Supported Escitalopram |
| EscitalopramAlso: Cipralex, LexaproPatients diagnosed with MDD and will fulfill the inclusion and exclusion criteria will start with escitalopram 10mg, according to the Summary of Product Characteristics. At week 2, patients with a baseline MADRS between 22 and 29 continue on 10mg, and patients with a baseline MADRS > 30 receive a fixed dose 20mg until the end of treatment. | Drug | Escitalopram |
Primary outcome
Sheehan Disability Scale
Time frame: Change from baseline to study completion by week 8.
The Sheehan Disability Scale (Sheehan 1983) is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by panic, anxiety, phobic, or depressive symptoms. This scale has been used widely in psychopharmacology randomized controlled trials, particularly for panic disorder. This anchored visual analog scale uses spatiovisual, numeric, and verbal descriptive anchors simultaneously to assess disability across three domains: work, social life, and family life.
1 secondary outcome
Montgomery Åsberg Depression Rating Scale
Time frame: Change from baseline to study completion in week 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Background: PubMed 19041717Gomeni R, Lavergne A, Merlo-Pich E. Modelling placebo response in depression trials using a longitudinal model with informative dropout. Eur J Pharm Sci. 2009 Jan 31;36(1):4-10. doi: 10.1016/j.ejps.2008.10.025. Epub 2008 Nov 8.
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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.
Yehuda Baruch, MD, MHA study chair
Abarbanel MHC, Israel.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram in people with Major Depressive Disorder, run by Abarbanel Mental Health Center at 1 site in Israel.
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 10 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: finished, as of the sponsor's last update on 24 Jun 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 Israel. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sheehan Disability Scale (time frame: Change from baseline to study completion by week 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480400, which also lists 1 linked publication.
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 24 Jun 2015.