DepressionPhase 2/3KETAPALNCT02783430
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
A Phase 2/3 study testing Ketamine and Milnacipran in people with Depression, run by University Hospital, Lille at 9 sites in France.
Trial summary
KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant action of ketamine in palliative care situations. Half of participants will receive Ketamine and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran in combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Ketamine and Milnacipran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 9 sitesFrance
- Study dates
- 8 Sep 2016to 8 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient
- Supported by a functional palliative care unit
- Having a severe and progressive disease diagnosed
- Meet the criteria for major depressive disorder as defined by DSM in its version 5
- MADRS > 19 ( moderate to severe)
- No antidepressant treatment or treatment introduced for more than four weeks
- In ability to receive clear information and give consent
- Beneficiary of a social security scheme
Who cannot join
- upper weight or equal to 100 kg
- ultimate phase (about 24 to 72 hours prior to death)
- unstable patient on cardiovascular diseases, including uncontrolled hypertension
- severe renal impairment (renal clearance less than 15 ml / min)
- psychiatric comorbidity: schizophrenia and schizoaffective disorder
- neurological comorbidity: recent cerebrovascular accident (Less than one month), Parkinson's disease, dementia
Show all 17Show fewer
- treatment with ketamine received in the four weeks preceding the inclusion
- impaired judgment, cognitive or massive sensory impairment not allowing to receive clear information
- oral antidepressant treatment introduced less than four weeks ago
- dosage of oral antidepressant treatment upper than the marketing authorization for more than four weeks
- patient not covered by the social security system
- refusal to sign the consent
- minor patient or guardianship
- pregnant women (implementation of a urine pregnancy test before inclusion for women of childbearing age)
- lactating women
- intolerance or allergic reaction to ketamine or milnacipran.
- contraindications to the association of ketamine or milnacipran with the patient's usual treatment
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Chu Amiens Picardie
Amiens
Ch Calais
Calais
Maison Medicale Jean Xxiii - Lille
Lille, 59037
University Hospital,
Lille
Groupt Hopitaux Instit Catho de Lille - Lomme
Lomme
C.H de Roubaix
Roubaix
Ch Ghpso Senlis
Senlis
Ch Tourcoing
Tourcoing
Centre Hospitalier de Valenciennes
Valenciennes
About this study
Official title: Evaluation of the Initial Prescription of Ketamine and Milnacipran Forin Depression in Patients With a Progressive Disease
KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant action of ketamine in palliative care situations. Half of participants will receive Ketamine and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran in combination.
Read the detailed description
Ketamine, a molecule mainly used as an analgesic in palliative care, turns out to be an excellent fast acting antidepressant. By acting as an NMDA receptor antagonist, its mechanism of action is complementary to classical and long acting antidepressants like Selective Serotonin Reuptake Inhibitors (SSRI). In particular, ketamine is able to boost synaptogenesis in only a few hours whereas long-term prescription of SSRI can stimulate neurogenesis.
The purpose of this study is to evaluate a new therapeutic strategy that could integrate ketamine in the same time than SSRI, to control depression symptoms faster and optimize patient's quality of life complementary to treatments of cancer.
- Conditions
- Depression
- Being tested
- Ketamine, Milnacipran, Placebo
- Keywords
- Ketamine, Palliative care, Supportive care, Early palliative care, Fast acting antidepressant, End of life care, Cancer, psychological distress, antidepressant, serotonin norepinephrine reuptake inhibitors
- Medical subject headings
- Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
One single perfusion of 0.5 mg/kg during 40 minutes at the beginning of the inclusion
MilnacipranDrug
One or two caps per day from the beginning of the inclusion. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day)
PlaceboDrug
One single perfusion during 40 minutes at the beginning of the inclusion
| Study group | Role | What they receive |
|---|---|---|
| Milnacipran + Ketamine | Experimental | Ketamine 0,5mg/kg single intravenous perfusion during 40 minutes. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day) Receives: Drug: Ketamine; Drug: Milnacipran |
| Milnacipran + Placebo | Active comparator | Placebo single intravenous perfusion during 40 minutes. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day) Receives: Drug: Milnacipran; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS Score
Measure of the change of Depression Intensity
Measured: At day 1, At day 2
Secondary outcomes (7)
EUROHIS-QOL 8
Measure of the improvement of quality of life after 15 days of treatment. EUROHIS-QOL 8-item index, a shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version (WHOQOL-BREF).
Measured: at day 0, at day 15
Number of request of early death (suicidal intentions or euthanasia or physician-assisted suicide)
measure request of suicidal intentions made by the patient on explicit request of the clinician.
Measured: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Hospital Anxiety and Depression scale (HAD)
The items of the scale limit confounding factors related to physical comorbidity . The answers are simple and quick . It is a wide choice and recommended for depression studies in palliative care.
Measured: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
MADRS Score
The MADRS scale quantifies the intensity of depressive symptoms, determine the number of responders (reduction in the initial score greater than or equal to 50%) and the number of patients in remission (score less than 7).
Measured: at day 0, at day 4, at day 8, at day 15
Clinical Global Impression (CGI) Score
These hetero fast and well validated assessments help to complete the assessment by the clinician on the severity of the patient's situation and overall improvement
Measured: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Global Assessment Scale Operation (EGF)
Global Assessment of Functioning is a numerical scale ( from 0 to 100) used to evaluate the psychological, social and work of an individual .
Measured: at day 0, at day 15
Edmonton Symptom Assessment System ( ESAS )
Symptom Assessment Scale
Measured: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start8 Sep 2016
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine LEMAIRE, MD, Study chair, Hospital of Valenciennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783430
- Sponsor's protocol ID
- 2014_22
- Other IDs
- 2014-004361-24, PHRCI_2013, 2014
- Acronym
- KETAPAL
- Status last verified
- Dec 2025
- First submitted
- 12 May 2016
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Undecided yet
Publications
Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 2011 Jun 10;29(17):2319-26. doi: 10.1200/JCO.2010.32.4459. Epub 2011 May 9.
PubMed 21555700Lepine JP, Gasquet I, Kovess V, Arbabzadeh-Bouchez S, Negre-Pages L, Nachbaur G, Gaudin AF. [Prevalence and comorbidity of psychiatric disorders in the French general population]. Encephale. 2005 Mar-Apr;31(2):182-94. doi: 10.1016/s0013-7006(05)82385-1. French.
PubMed 15959445Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19.
PubMed 21251875Atassi N, Cook A, Pineda CM, Yerramilli-Rao P, Pulley D, Cudkowicz M. Depression in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2011 Mar;12(2):109-12. doi: 10.3109/17482968.2010.536839. Epub 2010 Nov 24.
PubMed 21091399Rutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006 Oct 17;48(8):1527-37. doi: 10.1016/j.jacc.2006.06.055. Epub 2006 Sep 26.
PubMed 17045884Araujo SM, de Bruin VM, Daher Ede F, Almeida GH, Medeiros CA, de Bruin PF. Risk factors for depressive symptoms in a large population on chronic hemodialysis. Int Urol Nephrol. 2012 Aug;44(4):1229-35. doi: 10.1007/s11255-011-0032-9. Epub 2011 Jul 22.
PubMed 21779919Koenig HG, George LK, Peterson BL, Pieper CF. Depression in medically ill hospitalized older adults: prevalence, characteristics, and course of symptoms according to six diagnostic schemes. Am J Psychiatry. 1997 Oct;154(10):1376-83. doi: 10.1176/ajp.154.10.1376.
PubMed 9326819Lloyd-Williams M, Friedman T, Rudd N. A survey of antidepressant prescribing in the terminally ill. Palliat Med. 1999 May;13(3):243-8. doi: 10.1191/026921699676753309.
PubMed 10474711Goldberg RJ, Mor V. A survey of psychotropic use in terminal cancer patients. Psychosomatics. 1985 Sep;26(9):745-8, 751. doi: 10.1016/S0033-3182(85)72803-4. No abstract available.
PubMed 4048377Rumsfeld JS, Havranek E, Masoudi FA, Peterson ED, Jones P, Tooley JF, Krumholz HM, Spertus JA; Cardiovascular Outcomes Research Consortium. Depressive symptoms are the strongest predictors of short-term declines in health status in patients with heart failure. J Am Coll Cardiol. 2003 Nov 19;42(10):1811-7. doi: 10.1016/j.jacc.2003.07.013.
PubMed 14642693Cubo E, Bernard B, Leurgans S, Raman R. Cognitive and motor function in patients with Parkinson's disease with and without depression. Clin Neuropharmacol. 2000 Nov-Dec;23(6):331-4. doi: 10.1097/00002826-200011000-00006.
PubMed 11575867Lyketsos CG, Steele C, Baker L, Galik E, Kopunek S, Steinberg M, Warren A. Major and minor depression in Alzheimer's disease: prevalence and impact. J Neuropsychiatry Clin Neurosci. 1997 Fall;9(4):556-61. doi: 10.1176/jnp.9.4.556.
PubMed 9447496Aimonino N, Tibaldi V, Barale S, Bardelli B, Pilon S, Marchetto C, Zanocchi M, Molaschi M. Depressive symptoms and quality of life in elderly patients with exacerbation of chronic obstructive pulmonary disease or cardiac heart failure: preliminary data of a randomized controlled trial. Arch Gerontol Geriatr. 2007;44 Suppl 1:7-12. doi: 10.1016/j.archger.2007.01.002.
PubMed 17317428Newport DJ, Nemeroff CB. Assessment and treatment of depression in the cancer patient. J Psychosom Res. 1998 Sep;45(3):215-37. doi: 10.1016/s0022-3999(98)00011-7.
PubMed 9776368Rhondali W, Perceau E, Berthiller J, Saltel P, Trillet-Lenoir V, Tredan O, Coulon JP, Bruera E, Filbet M. Frequency of depression among oncology outpatients and association with other symptoms. Support Care Cancer. 2012 Nov;20(11):2795-802. doi: 10.1007/s00520-012-1401-3. Epub 2012 Feb 17.
PubMed 22350596
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Initial Prescription of Ketamine and Milnacipran Forin Depression in Patients With a Progressive Disease
- ClinicalTrials.gov ID
- NCT02783430
- Acronym / sponsor ID
- KETAPAL / 2014_22
- Conditions
- Depression
- Keywords
- Ketamine, Palliative care, Supportive care, Early palliative care, Fast acting antidepressant, End of life care, Cancer, psychological distress
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 Sep 2016 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 26 May 2016 (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.
KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant action of ketamine in palliative care situations. Half of participants will receive Ketamine and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran in combination.
Detailed description
Ketamine, a molecule mainly used as an analgesic in palliative care, turns out to be an excellent fast acting antidepressant. By acting as an NMDA receptor antagonist, its mechanism of action is complementary to classical and long acting antidepressants like Selective Serotonin Reuptake Inhibitors (SSRI). In particular, ketamine is able to boost synaptogenesis in only a few hours whereas long-term prescription of SSRI can stimulate neurogenesis.
The purpose of this study is to evaluate a new therapeutic strategy that could integrate ketamine in the same time than SSRI, to control depression symptoms faster and optimize patient's quality of life complementary to treatments of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milnacipran + Ketamine | Experimental | Drug: Ketamine, Drug: MilnacipranKetamine 0,5mg/kg single intravenous perfusion during 40 minutes. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day) |
| Milnacipran + Placebo | Active comparator | Drug: Milnacipran, Drug: PlaceboPlacebo single intravenous perfusion during 40 minutes. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Inpatient
- Supported by a functional palliative care unit
- Having a severe and progressive disease diagnosed
- Meet the criteria for major depressive disorder as defined by DSM in its version 5
- MADRS > 19 ( moderate to severe)
Key exclusion criteria (17 listed)
- upper weight or equal to 100 kg
- ultimate phase (about 24 to 72 hours prior to death)
- unstable patient on cardiovascular diseases, including uncontrolled hypertension
- severe renal impairment (renal clearance less than 15 ml / min)
- psychiatric comorbidity: schizophrenia and schizoaffective disorder
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 |
|---|---|---|
| KetamineOne single perfusion of 0.5 mg/kg during 40 minutes at the beginning of the inclusion | Drug | Milnacipran + Ketamine |
| MilnacipranOne or two caps per day from the beginning of the inclusion. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day) | Drug | Milnacipran + Ketamine, Milnacipran + Placebo |
| PlaceboOne single perfusion during 40 minutes at the beginning of the inclusion | Drug | Milnacipran + Placebo |
Primary outcome
MADRS Score
Time frame: At day 1, At day 2
Measure of the change of Depression Intensity
7 secondary outcomes
EUROHIS-QOL 8
Time frame: at day 0, at day 15
Number of request of early death (suicidal intentions or euthanasia or physician-assisted suicide)
Time frame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Hospital Anxiety and Depression scale (HAD)
Time frame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
MADRS Score
Time frame: at day 0, at day 4, at day 8, at day 15
Clinical Global Impression (CGI) Score
Time frame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Global Assessment Scale Operation (EGF)
Time frame: at day 0, at day 15
Edmonton Symptom Assessment System ( ESAS )
Time frame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
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 16 Dec 2025.
- Background: PubMed 21555700Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 2011 Jun 10;29(17):2319-26. doi: 10.1200/JCO.2010.32.4459. Epub 2011 May 9.
- Background: PubMed 15959445Lepine JP, Gasquet I, Kovess V, Arbabzadeh-Bouchez S, Negre-Pages L, Nachbaur G, Gaudin AF. [Prevalence and comorbidity of psychiatric disorders in the French general population]. Encephale. 2005 Mar-Apr;31(2):182-94. doi: 10.1016/s0013-7006(05)82385-1. French.
- Background: PubMed 21251875Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19.
- Background: PubMed 21091399Atassi N, Cook A, Pineda CM, Yerramilli-Rao P, Pulley D, Cudkowicz M. Depression in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2011 Mar;12(2):109-12. doi: 10.3109/17482968.2010.536839. Epub 2010 Nov 24.
- Background: PubMed 17045884Rutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006 Oct 17;48(8):1527-37. doi: 10.1016/j.jacc.2006.06.055. Epub 2006 Sep 26.
- Background: PubMed 21779919Araujo SM, de Bruin VM, Daher Ede F, Almeida GH, Medeiros CA, de Bruin PF. Risk factors for depressive symptoms in a large population on chronic hemodialysis. Int Urol Nephrol. 2012 Aug;44(4):1229-35. doi: 10.1007/s11255-011-0032-9. Epub 2011 Jul 22.
- Background: PubMed 9326819Koenig HG, George LK, Peterson BL, Pieper CF. Depression in medically ill hospitalized older adults: prevalence, characteristics, and course of symptoms according to six diagnostic schemes. Am J Psychiatry. 1997 Oct;154(10):1376-83. doi: 10.1176/ajp.154.10.1376.
- Background: PubMed 10474711Lloyd-Williams M, Friedman T, Rudd N. A survey of antidepressant prescribing in the terminally ill. Palliat Med. 1999 May;13(3):243-8. doi: 10.1191/026921699676753309.
- Background: PubMed 4048377Goldberg RJ, Mor V. A survey of psychotropic use in terminal cancer patients. Psychosomatics. 1985 Sep;26(9):745-8, 751. doi: 10.1016/S0033-3182(85)72803-4. No abstract available.
- Background: PubMed 14642693Rumsfeld JS, Havranek E, Masoudi FA, Peterson ED, Jones P, Tooley JF, Krumholz HM, Spertus JA; Cardiovascular Outcomes Research Consortium. Depressive symptoms are the strongest predictors of short-term declines in health status in patients with heart failure. J Am Coll Cardiol. 2003 Nov 19;42(10):1811-7. doi: 10.1016/j.jacc.2003.07.013.
- Background: PubMed 11575867Cubo E, Bernard B, Leurgans S, Raman R. Cognitive and motor function in patients with Parkinson's disease with and without depression. Clin Neuropharmacol. 2000 Nov-Dec;23(6):331-4. doi: 10.1097/00002826-200011000-00006.
- Background: PubMed 9447496Lyketsos CG, Steele C, Baker L, Galik E, Kopunek S, Steinberg M, Warren A. Major and minor depression in Alzheimer's disease: prevalence and impact. J Neuropsychiatry Clin Neurosci. 1997 Fall;9(4):556-61. doi: 10.1176/jnp.9.4.556.
- Individual participant dataSharing planned: Undecided. Undecided yet
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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.
Antoine LEMAIRE, MD study chair
Hospital of Valenciennes
9 sites 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 Ketamine and Milnacipran in people with Depression, run by University Hospital, Lille at 9 sites in France.
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 8 inclusion and 17 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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 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?
MADRS Score (time frame: At day 1, At day 2). 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 NCT02783430, which also lists 52 linked publications.
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 16 Dec 2025.