Major Depressive Disorder With Suicidal Ideation With Intent Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomized Dose-ranging Trial to Investigate Efficacy and Safety of Intravenous MIJ821 Infusion in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent
| Verified date | October 2023 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study of efficacy and safety of MIJ821 in addition to comprehensive standard of care on the rapid reduction of symptoms of Major Depressive Disorder (MDD) in subjects who have suicidal ideation with intent
| Status | Terminated |
| Enrollment | 200 |
| Est. completion date | September 26, 2023 |
| Est. primary completion date | September 26, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study 2. Male and female participants, 18 to 65 years of age (inclusive) at screening 3. DSM-5 defined major depressive disorder (MDD) with a current major depressive episode (MDE) without psychotic features at the time of screening based upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) assessed at Screening 4. Participants must have current suicidal ideation with intent, confirmed by a "Yes" response to Question B3 AND either Question B10 or Question B11 obtained from the M.I.N.I., assessed at Screening 5. Current suicidal ideation with intent, confirmed by "Yes" response to Question 3 AND either Question 9 or Question 10 obtained from the SSTS at Baseline 6. Montgomery-Åsberg Depression Rating Scale (MADRS) score > 28 at Screening and before randomization on Day 1 7. Participants must agree to receive pharmacological standard of care treatment to treat their MDD (as determined by the treating physician(s) based on clinical judgement and local treatment guidelines) during the trial duration 8. In the physician's opinion, acute psychiatric hospitalization is clinically warranted to treat the patient's condition, and the patient is either already in the hospital or agrees to be hospitalized voluntarily for the required per protocol period Exclusion Criteria: 1. Any prior or current diagnosis of bipolar disorder, MDD with psychotic features, schizophrenia, or schizoaffective disorder as obtained from M.I.N.I. at Screening 2. Patients with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or patients who went through detoxification treatment (inpatient or outpatient) within 1 month before Screening. 3. Participant has a current clinical diagnosis of autism, dementia, or intellectual disability 4. History of seizures. Note: childhood febrile seizures are not exclusionary 5. Participants with borderline personality disorder as obtained from M.I.N.I. at Screening. 6. Participants with suicidal ideation or behavior caused primarily by another non-MDD condition as obtained from M.I.N.I. at Screening 7. Participants taking medications prohibited by the protocol 8. Intake of the following medications/ psychotherapy: 1. Esketamine or Ketamine 2 months before Screening 2. Monoamine oxidase inhibitors (MAOIs) 14 days before Screening 3. Non-stable psychotherapy regimen and/or started less than 6 weeks before Screening 9. Any other condition (e.g. known liver disease/liver dysfunction, active malignancy, etc.) which in the opinion of the investigator would put the safety of the participant at risk, impede compliance or hinder completion of the study. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novartis Investigative Site | Buenos Aires | |
| Brazil | Novartis Investigative Site | Fortaleza | Ceara |
| Brazil | Novartis Investigative Site | Sao Bernardo do Campo | Sao Paulo |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Muenchen | |
| Japan | Novartis Investigative Site | Bunkyo-ku | Tokyo |
| Japan | Novartis Investigative Site | Kodaira | Tokyo |
| Japan | Novartis Investigative Site | Toyoake-city | Aichi |
| Malaysia | Novartis Investigative Site | Kuala Lumpur | |
| Malaysia | Novartis Investigative Site | Seremban | Negeri Sembilan |
| Mexico | Novartis Investigative Site | Mazatlan | Sinaloa |
| Mexico | Novartis Investigative Site | Monterrey | Nuevo Leon |
| Mexico | Novartis Investigative Site | San Luis Potosi | |
| Netherlands | Novartis Investigative Site | Groningen | |
| Poland | Novartis Investigative Site | Bialystok | |
| Poland | Novartis Investigative Site | Gdansk | |
| Poland | Novartis Investigative Site | Lodz | Lodzkie |
| Poland | Novartis Investigative Site | Pruszkow | Mazowieckie |
| Poland | Novartis Investigative Site | Swiecie n/W | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Barcelona | |
| Spain | Novartis Investigative Site | Barcelona | |
| Spain | Novartis Investigative Site | Palma De Mallorca | Islas Baleares |
| Spain | Novartis Investigative Site | Vitoria-Gasteiz | Pais Vasco |
| Taiwan | Novartis Investigative Site | Taipei | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Turkey | Novartis Investigative Site | Bursa | Gorukle |
| Turkey | Novartis Investigative Site | Istanbul | TUR |
| Turkey | Novartis Investigative Site | Izmir | |
| United States | Novartis Investigative Site | Atlanta | Georgia |
| United States | Novartis Investigative Site | Birmingham | Alabama |
| United States | Novartis Investigative Site | DeSoto | Texas |
| United States | Novartis Investigative Site | Farmington | Connecticut |
| United States | Novartis Investigative Site | Oakland Park | Florida |
| United States | Novartis Investigative Site | Rockville | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Argentina, Brazil, Canada, Germany, Japan, Malaysia, Mexico, Netherlands, Poland, Russian Federation, Spain, Taiwan, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in the total score of the Montgomery Åsberg Depression Rating Scale (MADRS) | The Montgomery Åsberg Depression Rating Scale (MADRS, SIGMA version), is a clinician rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts and suicidal thoughts. The MADRS will be collected electronically by qualified personnel | Baseline (first infusion) at 24 hours and up to 52 weeks | |
| Secondary | Number and severity of treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESI) | Treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) will be collected at all study visits | Baseline up to 6 weeks | |
| Secondary | Pharmacokinetics (PK) of MIJ821 in plasma | PK parameters of MIJ821 in plasma after 1st infusion described by AUClast, Cmax, Tmax and after each other infusion described by Cmax and Tmax. In order to better define the PK profile, the timing of the PK sample collection may be altered based on emergent data. | Baseline up to 52 weeks | |
| Secondary | Percentage of participants meeting response criteria of =50% reduction | Response criteria of =50% reduction from baseline in MADRS total score over time in the Core Period. | Baseline up to 6 weeks | |
| Secondary | Percentage of participants meeting criteria for sustained response of =50% reduction | Sustained response from baseline in MADRS total score for a period of at least four weeks in the Core Period | Baseline up to 6 weeks | |
| Secondary | Percentage of participants meeting remission criteria of MADRS total score of =12 | Remission criteria of MADRS total score of =12 over time in the Core Period | Baseline up to 6 weeks | |
| Secondary | Percentage of participants meeting sustained remission criteria of MADRS total score of =12 | Remission criteria of MADRS total score of =12 sustained for a period of at least four weeks in the Core Period | Baseline up to 6 weeks | |
| Secondary | Percentage of participants meeting criteria for relapse in the Extension Period | Relapse for all patients meeting criteria for relapse over fixed period in the Extension Period | From 6 weeks up to 52 weeks | |
| Secondary | Percentage of relapsing participants meeting response criteria or remission criteria after the first infusion | Relapsing participants meeting response criteria or remission criteria after the first infusion of MIJ821 retreatment in the Extension Period | From 6 weeks up to 52 weeks |