Major Depressive DisorderPhase 2NCT03965858
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression
A Phase 2 study testing Esketamine DPI - low dose, Esketamine DPI - medium dose and Esketamine DPI - high dose in people with Major Depressive Disorder, run by Celon Pharma SA at 12 sites in Poland.
Trial summary
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant depression (TRD) in the course of Major Depressive Disorder (MDD). The study is to determine the efficacy and dose response of three Esketamine doses, compared with placebo. 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?
- Esketamine DPI - low dose, Esketamine DPI - medium dose and Esketamine DPI - high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 12 sitesPoland
- Study dates
- 25 Feb 2019to 24 Apr 2020
- Phase
- Phase 2
- 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
- Gender: female or male,
- Age: 18 - 65 years old, inclusive, on the day of Screening,
- Participant must meet Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnostic criteria for major depressive disorder, without psychotic features, confirmed by the Mini International Neuropsychiatric Interview (MINI),
- Participant must have in Montgomery-Asberg Depression Rating Scale (MADRS) total score of >= 25 at Screening and predose on Day 1,
- Participant is treatment resistant, defined as having an inadequate response to at least 2 antidepressants administered for the sufficient duration and dose, both in the current episode of depression,
- Participant must be on stable monotherapy with antidepressant drug (listed in the protocol) remain non-responsive to it and continue on non-investigational antidepressant therapy from Screening to at least the duration of the double-blind treatment phase,
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- Participant agrees to be hospitalized voluntarily for a period of 12 h before first administration and until the Day 6 of treatment phase. Hospitalization from Day 6 up to the end of treatment phase on Day 14 is up to Investigator discretion, with exception of mandatory hospitalization from 12 h before each administration until 24 h post each administration and from evening on Day 13 until the end of examinations on Day 14,
- Participant must be medically stable on the basis of clinical laboratory tests, physical examination, vital signs, 12-lead ECG,
- Participant agrees to blood sample collection for DNA analysis,
- Participant of childbearing potential willing to use acceptable forms of contraception.
Who cannot join
- Participant has a current DSM-5 diagnosis, according to MINI, of any other than MDD disorder,
- Participant has suicidal ideation in MADRS 'suicidal thoughts' subscale score greater or equal to 2 and/or in C-SSRS score greater or equal to 4 at Screening and/or has a history of suicidal thoughts within 6 months prior to Screening and/or history of suicidal attempt within 1 year prior to Screening,
- Participant has a history or current signs and symptoms of chronic obstructive pulmonary disease (COPD), asthma, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, hematologic, neurologic, rheumatologic or metabolic disturbances that are uncontrolled with medication change during last three months before Screening and/or that could influence the present general health condition at the Investigator's discretion,
- Participant has uncontrolled hypertension,
- Upper respiratory tract and/or chest infection and/or inflammation within 2 weeks preceding the first administration and during the treatment phase,
- Participant took part in other clinical trial within 90 days preceding the Screening,
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- Known allergy or hypersensitivity, intolerance or contraindication to Esketamine/ketamine or its derivatives and/or to any study product excipients,
- Blood drawn within 30 days prior to inclusion to the study,
- History of drug, alcohol, chemical, sedatives or sleeping medications abuse or dependence (except nicotine or caffeine) within 2 years prior to Screening,
- Lifetime abuse or dependence on ketamine or phencyclidine,
- Positive results from pregnancy test for female participants,
- Lactation in female participants,
- Positive drug screen (except benzodiazepines evaluation during follow-up) or alcohol breath test.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Poland12 sites
Wojewodzki Szpital im. Jana Pawła II
Bełchatów, 97-400
Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych
Bolesławiec, 59-700
Samodzielny Publiczny Psychiatryczny Zaklad Opieki Zdrowotnej
Choroszcz, 16-070
Szpital Miejski
Elblag, 82-300
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych
Gmina Świecie, 86-100
Gornoslaskie Centrum Medyczne
Katowice, 40-635
Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej
Lodz, 91-229
Pabianickie Centrum Medyczne
Pabianice, 95-200
Mazowieckie Specalistyczne Centrum Zdrowia
Pruszków, 05-802
Mazowiecki Szpital i Centrum Diagnostyczne Allenort
Warsaw, 03-185
Uniwersytecki Szpital Kliniczny
Wroclaw, 50-556
About this study
Official title: A Multicentre, Double-blind, Randomised, Placebo - Controlled Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Depression in the Course of Major Depressive Disorder
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant depression (TRD) in the course of Major Depressive Disorder (MDD). The study is to determine the efficacy and dose response of three Esketamine doses, compared with placebo.
Read the detailed description
This is a randomized, multiple dose, placebo-controlled, double-blind, multicentre study of Esketamine DPI, inhalation powder delivered via dry powder inhaler (DPI) in participants with TRD in the course of MDD. There are 3 study phases: Screening phase, a two weeks double-blind treatment phase and a 6-week follow-up phase. Participants are to be randomized in 1:1:1:1 ratio to receive placebo or one of the three doses of Esketamine DPI. Participants from each group will receive different dosing sequences, consider as a single dose, corresponding to low, medium, high Esketamine dose or placebo. Participants will undergo one cycle of treatment consisting of four doses of Esketamine DPI or placebo over 14-day period. Participants safety will be monitored throughout the study.
- Conditions
- Major Depressive Disorder
- Being tested
- Esketamine DPI - low dose, Esketamine DPI - medium dose, Esketamine DPI - high dose, Placebo DPI
- 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.
Esketamine DPI - low doseDrug
Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to low Esketamine dose.
Esketamine DPI - medium doseDrug
Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to medium Esketamine dose.
Esketamine DPI - high doseDrug
Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to high Esketamine dose.
Placebo DPIDrug
Placebo DPI is to be administered via dry powder inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Esketamine low dose | Experimental | Participants are to receive four doses of Esketamine DPI administered over 14-day period (on Day 1, 4, 8 and 11). Receives: Drug: Esketamine DPI - low dose |
| Esketamine medium dose | Experimental | Participants are to receive four doses of Esketamine DPI administered over 14-day period (on Day 1, 4, 8 and 11). Receives: Drug: Esketamine DPI - medium dose |
| Esketamine high dose | Experimental | Participants are to receive four doses of Esketamine DPI administered over 14-day period (on Day 1, 4, 8 and 11). Receives: Drug: Esketamine DPI - high dose |
| Placebo | Placebo comparator | Participants are to receive four doses of Placebo DPI administered over 14-day period (on Day 1, 4, 8 and 11). Receives: Drug: Placebo DPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 14
The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The test consists of 10 items, each scored from 0 (symptoms not present or normal) to 6 (severe or continuous presence of the symptoms). Total score is 60. The higher MADRS total score, the more severe depression.
Measured: Day 1 and Day 14
Secondary outcomes (25)
Change from baseline in MADRS total score at each other than Day 14 timepoint
The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The test consists of 10 items, each scored from 0 (symptoms not present or normal) to 6 (severe or continuous presence of the symptoms). Total score is 60. The higher MADRS total score, the more severe depression.
Measured: Day 1, 2, 4, 5, 8, 9, 11, 12 and week 3, 4, 5, 6, 7 and 8
Number of participants with clinical response (>= 50% decrease in MADRS baseline score)
Clinical response is to be defined as greater than or equal to 50 % decrease in MADRS baseline score at Day 14 and every other timepoint.
Measured: Day 1, 2, 4, 5, 8, 9, 11, 12, 14 and up to 6 weeks after the treatment phase
Onset of clinical response that was sustained through the end of the 2-week, double-blind, treatment phase
Measured: Day 1, 2, 4, 5, 8, 9, 11, 12, 14
Change from baseline in depression severity, measured by Hamilton Depression Rating Scale (HDRS) at every timepoint
HDRS is a questionnaire used to rate the severity of depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss and somatic symptoms. HDRS consists of 17 questions with maximum 4-points scale. The higher HDRS total score, the more severe depression.
Measured: Day 1, 2, 4, 5, 8, 9, 11, 12, 14 and week 3, 4, 5, 6, 7 and 8
Number of participants with clinical remission (MADRS total score <= 10)
Clinical remission, defined as MADRS total score less than or equal to 10.
Measured: Day 1, 2, 4, 5, 8, 9, 11, 12, 14 and up to 6 weeks after the treatment phase
Time to relapse
Relapse assessed for responders and remitters and defined when MADRS total score in 2 consecutive assessments after Day 14 exceeds 50% MADRS baseline total score value.
Measured: Day 14 and week 3, 4, 5, 6, 7 and 8
Change from baseline in Clinical Global Impression - Severity (CGI-S) score at Day 14 and every other timepoint
CGI-S scale is a physician-rated scale that is designed to rate the severity of the patient's illness at the time of assessment. It is a 7-point assessment where 1 = normal (not at all ill) and 7 = among the most extremely ill patients.
Measured: Day 1, 2, 4, 5, 8, 9, 11, 12, 14 and week 3, 4, 5, 6, 7 and 8
Change from baseline in Columbia Suicide Severity Rating Scale (C-SSRS) at Day 14 and every other timepoint
C-SSRS is a suicide ideation rating scale created by researchers at Columbia University.
Measured: Day 1, 14 and week 5, 8
Change from baseline in the Clinician Administered Dissociative States Scale (CADSS) at each day of administration
CADSS is a scale designed to assess dissociative symptoms. CADSS consists of 23 questions with 4-points scale, where 1=normal (not at all) and 4=Extremely. The higher CADSS total score, the more severe symptoms.
Measured: up to 24 hours following the start of each administration
Change from baseline in the Brief Psychiatric Rating Scale (BPRS) at each day of administration
BPRS is a scale designed to rate psychotomimetic effects. BPRS consists of 18 questions with 7-points scale, from 1 (not present) to 7 (extremaly severe). The higher BPRS total score, the more severe effects.
Measured: up to 24 hours following the start of each administration
Potential withdrawal symptoms after Esketamine treatment, as measured by the 20-item Physician Withdrawal Checklist (PWC-20)
PWC-20 is a method to assess discontinuation symptoms.
Measured: Day 0, week 3, 4 and 5
Potential Esketamine effect on cognition as measured by Montreal Cognitive Assessment (MoCA)
MoCA is a screening assessment for detecting cognitive impairment.
Measured: Day 0, week 4 and 8
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: up to 8 weeks
Esketamine AUC0-24h - area under the plasma concentration - time curve from time 0 to 24 h
Measured: up to 24 hours following the start of first and fourth administration
Esketamine Cmax - maximum plasma concentration
Measured: up to 24 hours following the start of first and fourth administration
Esketamine AUC0-inf - area under the plasma concentration - time curve from time 0 to infinity
Measured: up to 24 hours following the start of first and fourth administration
Esketamine Kel - terminal elimination rate constant
Measured: up to 24 hours following the start of first and fourth administration
Esketamine t1/2 - plasma elimination half-life
Measured: up to 24 hours following the start of first and fourth administration
Esketamine Tmax - time to reach maximum concentration in plasma
Measured: up to 24 hours following the start of first and fourth administration
Esnorketamine AUC0-24h - area under the plasma concentration - time curve from time 0 to 24 h
Measured: up to 24 hours following the start of first and fourth administration
Esnorketamine Cmax - maximum plasma concentration
Measured: up to 24 hours following the start of first and fourth administration
Esnorketamine Tmax - time to reach maximum concentration in plasma
Measured: up to 24 hours following the start of first and fourth administration
Changes between predose and postdose values for each administration in hematology and biochemistry
Measured: up to 6 weeks
Changes between predose and postdose values for each administration in vital signs (heart rate, blood pressure, respiratory rate) and urinalysis
Measured: up to 8 weeks
Changes between predose and postdose values for each administration in SpO2 (blood oxygen saturation)
Measured: up to 2 hours following the start of each administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start25 Feb 2019
- Primary completion15 Mar 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celon Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965858
- Sponsor's protocol ID
- 02KET2018
- Status last verified
- Apr 2020
- First submitted
- 21 May 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double-blind, Randomised, Placebo - Controlled Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Depression in the Course of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03965858
- Acronym / sponsor ID
- 02KET2018
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Celon Pharma SAIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 29 May 2019 (actual)
- 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 purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant depression (TRD) in the course of Major Depressive Disorder (MDD). The study is to determine the efficacy and dose response of three Esketamine doses, compared with placebo.
Detailed description
This is a randomized, multiple dose, placebo-controlled, double-blind, multicentre study of Esketamine DPI, inhalation powder delivered via dry powder inhaler (DPI) in participants with TRD in the course of MDD. There are 3 study phases: Screening phase, a two weeks double-blind treatment phase and a 6-week follow-up phase. Participants are to be randomized in 1:1:1:1 ratio to receive placebo or one of the three doses of Esketamine DPI. Participants from each group will receive different dosing sequences, consider as a single dose, corresponding to low, medium, high Esketamine dose or placebo. Participants will undergo one cycle of treatment consisting of four doses of Esketamine DPI or placebo over 14-day period. Participants safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Esketamine low dose | Experimental | Drug: Esketamine DPI - low doseParticipants are to receive four doses of Esketamine DPI administered over 14-day period (on Day 1, 4, 8 and 11). |
| Esketamine medium dose | Experimental | Drug: Esketamine DPI - medium doseParticipants are to receive four doses of Esketamine DPI administered over 14-day period (on Day 1, 4, 8 and 11). |
| Esketamine high dose | Experimental | Drug: Esketamine DPI - high doseParticipants are to receive four doses of Esketamine DPI administered over 14-day period (on Day 1, 4, 8 and 11). |
| Placebo | Placebo comparator | Drug: Placebo DPIParticipants are to receive four doses of Placebo DPI administered over 14-day period (on Day 1, 4, 8 and 11). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Gender: female or male,
- Age: 18 - 65 years old, inclusive, on the day of Screening,
- Participant must meet Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnostic criteria for major depressive disorder, without psychotic features, confirmed by the Mini International Neuropsychiatric Interview (MINI),
- Participant must have in Montgomery-Asberg Depression Rating Scale (MADRS) total score of >= 25 at Screening and predose on Day 1,
- Participant is treatment resistant, defined as having an inadequate response to at least 2 antidepressants administered for the sufficient duration and dose, both in the current episode of depression,
Key exclusion criteria (13 listed)
- Participant has a current DSM-5 diagnosis, according to MINI, of any other than MDD disorder,
- Participant has suicidal ideation in MADRS 'suicidal thoughts' subscale score greater or equal to 2 and/or in C-SSRS score greater or equal to 4 at Screening and/or has a history of suicidal thoughts within 6 months prior to Screening and/or history of suicidal attempt within 1 year prior to Screening,
- Participant has a history or current signs and symptoms of chronic obstructive pulmonary disease (COPD), asthma, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, hematologic, neurologic, rheumatologic or metabolic disturbances that are uncontrolled with medication change during last three months before Screening and/or that could influence the present general health condition at the Investigator's discretion,
- Participant has uncontrolled hypertension,
- Upper respiratory tract and/or chest infection and/or inflammation within 2 weeks preceding the first administration and during the treatment phase,
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 |
|---|---|---|
| Esketamine DPI - low doseEsketamine DPI is to be administered via dry powder inhaler. Each dose correspond to low Esketamine dose. | Drug | Esketamine low dose |
| Esketamine DPI - medium doseEsketamine DPI is to be administered via dry powder inhaler. Each dose correspond to medium Esketamine dose. | Drug | Esketamine medium dose |
| Esketamine DPI - high doseEsketamine DPI is to be administered via dry powder inhaler. Each dose correspond to high Esketamine dose. | Drug | Esketamine high dose |
| Placebo DPIPlacebo DPI is to be administered via dry powder inhaler. | Drug | Placebo |
Primary outcome
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 14
Time frame: Day 1 and Day 14
The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The test consists of 10 items, each scored from 0 (symptoms not present or normal) to 6 (severe or continuous presence of the symptoms). Total score is 60. The higher MADRS total score, the more severe depression.
25 secondary outcomes
Change from baseline in MADRS total score at each other than Day 14 timepoint
Time frame: Day 1, 2, 4, 5, 8, 9, 11, 12 and week 3, 4, 5, 6, 7 and 8
Number of participants with clinical response (>= 50% decrease in MADRS baseline score)
Time frame: Day 1, 2, 4, 5, 8, 9, 11, 12, 14 and up to 6 weeks after the treatment phase
Onset of clinical response that was sustained through the end of the 2-week, double-blind, treatment phase
Time frame: Day 1, 2, 4, 5, 8, 9, 11, 12, 14
Change from baseline in depression severity, measured by Hamilton Depression Rating Scale (HDRS) at every timepoint
Time frame: Day 1, 2, 4, 5, 8, 9, 11, 12, 14 and week 3, 4, 5, 6, 7 and 8
Number of participants with clinical remission (MADRS total score <= 10)
Time frame: Day 1, 2, 4, 5, 8, 9, 11, 12, 14 and up to 6 weeks after the treatment phase
Time to relapse
Time frame: Day 14 and week 3, 4, 5, 6, 7 and 8
Change from baseline in Clinical Global Impression - Severity (CGI-S) score at Day 14 and every other timepoint
Time frame: Day 1, 2, 4, 5, 8, 9, 11, 12, 14 and week 3, 4, 5, 6, 7 and 8
Change from baseline in Columbia Suicide Severity Rating Scale (C-SSRS) at Day 14 and every other timepoint
Time frame: Day 1, 14 and week 5, 8
Change from baseline in the Clinician Administered Dissociative States Scale (CADSS) at each day of administration
Time frame: up to 24 hours following the start of each administration
Change from baseline in the Brief Psychiatric Rating Scale (BPRS) at each day of administration
Time frame: up to 24 hours following the start of each administration
Potential withdrawal symptoms after Esketamine treatment, as measured by the 20-item Physician Withdrawal Checklist (PWC-20)
Time frame: Day 0, week 3, 4 and 5
Potential Esketamine effect on cognition as measured by Montreal Cognitive Assessment (MoCA)
Time frame: Day 0, week 4 and 8
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to 8 weeks
Esketamine AUC0-24h - area under the plasma concentration - time curve from time 0 to 24 h
Time frame: up to 24 hours following the start of first and fourth administration
Esketamine Cmax - maximum plasma concentration
Time frame: up to 24 hours following the start of first and fourth administration
Esketamine AUC0-inf - area under the plasma concentration - time curve from time 0 to infinity
Time frame: up to 24 hours following the start of first and fourth administration
Esketamine Kel - terminal elimination rate constant
Time frame: up to 24 hours following the start of first and fourth administration
Esketamine t1/2 - plasma elimination half-life
Time frame: up to 24 hours following the start of first and fourth administration
Esketamine Tmax - time to reach maximum concentration in plasma
Time frame: up to 24 hours following the start of first and fourth administration
Esnorketamine AUC0-24h - area under the plasma concentration - time curve from time 0 to 24 h
Time frame: up to 24 hours following the start of first and fourth administration
Esnorketamine Cmax - maximum plasma concentration
Time frame: up to 24 hours following the start of first and fourth administration
Esnorketamine Tmax - time to reach maximum concentration in plasma
Time frame: up to 24 hours following the start of first and fourth administration
Changes between predose and postdose values for each administration in hematology and biochemistry
Time frame: up to 6 weeks
Changes between predose and postdose values for each administration in vital signs (heart rate, blood pressure, respiratory rate) and urinalysis
Time frame: up to 8 weeks
Changes between predose and postdose values for each administration in SpO2 (blood oxygen saturation)
Time frame: up to 2 hours following the start of each administration
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 28 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esketamine DPI - low dose, Esketamine DPI - medium dose and Esketamine DPI - high dose in people with Major Depressive Disorder, run by Celon Pharma SA at 12 sites in Poland.
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 10 inclusion and 13 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Poland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 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?
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Day 14 (time frame: Day 1 and 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 28 Apr 2020.