Clinical TrialMajor Depressive Disorder (MDD)EsketaminePlaceboCompleted

A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide (ASPIRE I)

Double-blind, randomised, placebo-controlled Phase III trial (n=226) testing intranasal esketamine 84 mg twice weekly for 4 weeks plus standard of care versus intranasal placebo plus standard of care for rapid reduction of MDD symptoms including suicidal ideation in adults at imminent suicide risk.

Target Enrollment
226 participants
Study Type
Phase III interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, placebo-controlled multicentre study evaluating intranasal esketamine 84 mg versus intranasal placebo, each given with comprehensive standard of care, in adults hospitalised for imminent suicide risk due to Major Depressive Disorder.

Primary outcome is change from baseline in MADRS total score at 24 hours post first dose; study includes a 25-day double-blind treatment phase (Days 1–25) and 65-day follow-up (Day 26–90), total ~13 weeks per participant.

Study Protocol

Preparation

sessions

Dosing

8 sessions

Integration

sessions

Study Arms & Interventions

Esketamine + SOC

experimental

Intranasal esketamine 84 mg plus standard of care antidepressant treatment, administered twice weekly for 4 weeks (8 doses).

Interventions

  • Esketamine84 mg
    via Other• twice weekly• 8 doses total

    Days 1,4,8,11,15,18,22,25 (8 doses over 4 weeks).

  • Compound

    Standard of care antidepressant treatment (monotherapy or augmentation) as determined by treating physician, initiated Day 1.

Placebo + SOC

inactive

Intranasal placebo plus standard of care antidepressant treatment, administered twice weekly for 4 weeks (8 doses).

Interventions

  • Placebo0 mg
    via Other• twice weekly• 8 doses total

    Intranasal placebo on Days 1,4,8,11,15,18,22,25.

  • Compound

    Standard of care antidepressant treatment (monotherapy or augmentation) as determined by treating physician, initiated Day 1.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Participant must meet DSM-5 diagnostic criteria for Major Depressive Disorder (MDD), without psychotic features, based on clinical assessment and confirmed by the MINI.
  • In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to participant's imminent risk of suicide.
  • Participants must have current suicidal ideation with intent, confirmed by specific MINI items (B3 and B10); B3 must refer to the present; B10 may reflect past 24 hours; if screening >24 hours, repeat prior to randomization.
  • MADRS total score >28 predose on Day 1.
  • Participant agrees to be hospitalised voluntarily for a recommended period of 5 days after randomization (may vary if clinically warranted) and to take prescribed non-investigational antidepressant therapy(ies) for at least the double-blind treatment phase (Day 25).
  • Participant is comfortable with self-administration of intranasal medication and able to follow instructions provided.

Exclusion Criteria

  • Exclusion Criteria:
  • Current DSM-5 diagnosis of bipolar or related disorders, antisocial personality disorder, or obsessive compulsive disorder.
  • Current DSM-5 criteria for borderline personality disorder; participants not meeting full criteria but exhibiting recurrent suicidal gestures, threats, or self-mutilating behaviours should be excluded.
  • Current clinical diagnosis of autism, dementia, or intellectual disability.
  • Current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features.
  • Meets DSM-5 severity criteria for moderate or severe substance or alcohol use disorder (except nicotine or caffeine) within 6 months before screening.
  • Lifetime history of ketamine, PCP, LSD, or MDMA hallucinogen-related use disorder is exclusionary.

Study Details

Locations

UAB Department of Psychiatry and Behavioral Neurobiology — Birmingham, Alabama, United States
Metropolitan Neuro Behavioral Institute — Chandler, Arizona, United States
Collaborative NeuroScience Network — Garden Grove, California, United States
Yale University — New Haven, Connecticut, United States
Rush University — Chicago, Illinois, United States
Alexian Behavioral Health Hospital — Hoffman Estates, Illinois, United States
University of Louisville Department of Psychiatry — Louisville, Kentucky, United States
LSU Health Sciences Center New Orleans — New Orleans, Louisiana, United States
Louisiana Clinical Research — Shreveport, Louisiana, United States
Sheppard Pratt Health System — Baltimore, Maryland, United States
CBH Health — Gaithersburg, Maryland, United States
State University of New York — Buffalo, New York, United States
Columbia University Medical Center — New York, New York, United States
Clinical Trials of America — Hickory, North Carolina, United States
The Ohio State University — Columbus, Ohio, United States
Medical University of South Carolina — Charleston, South Carolina, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States
Regional Psychiatric Dispansery — Bulgaria, Bulgaria
Mental Health Center Prof. Dr. Ivan Temkov — Burgas, Bulgaria
State Psychiatric Hospital - Lovech — Lovech, Bulgaria
UMHAT 'Sveti Georgi'-Plovdiv — Plovdiv, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment Sofia — Sofia, Bulgaria
North Estonian Medical Centre Foundation — Tallinn, Estonia
Tartu University Hospital — Tartu, Estonia
Vivantes Humboldt Klinikum — Berlin, Germany
Universitatsklinikum Frankfurt — Frankfurt am Main, Germany
Klinik für Psychiatrie und Psychotherapie — Freiburg im Breisgau, Germany
Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu — Budapest, Hungary
Semmelweis Egyetem Kútvölgyi Klinikai Tömb — Budapest, Hungary
Nyiro Gyula Korhaz — Budapest, Hungary
Petz Aladar Megyei Oktato Korhaz — Győr, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont — Pécs, Hungary
University Kebangsaan Malaysia Medical Centre — Cheras, Malaysia
Hospital Kuala Lumpur — Kuala Lumpur, Malaysia
University Malaya Medical Centre — Kuala Lumpur, Malaysia
Hospital Tuanku Jaafar — Seremban, Malaysia
Fakultna nemocnica s poliklinikou v Ziline — Žilina, Slovakia
Flexivest 14 Research — Cape Town, South Africa
Juan Schrönen - Western Cape South Africa — Welgemoed, South Africa
Chonnam National University Hospital — Gwangju, South Korea
Korea University Ansan Hospital — Gyeonggi-do, South Korea
Kyung Hee University Medical Center — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Seoul National University Hospital — Seoul, South Korea
Hosp. Univ. Fundacion Alcorcon — Alcorcón, Spain
Hosp Univ Vall D Hebron — Barcelona, Spain
Hosp Clinic de Barcelona — Barcelona, Spain
Inst. Internac. Neurociencias Aplicadas — Barcelona, Spain
Hosp. Univ. de Basurto — Bilbao, Spain
Hosp. Univ. Ramon Y Cajal — Madrid, Spain
Clinica Univ. de Navarra — Pamplona, Spain
Benito Menni Comp. Asist. Salut Mental — Sant Boi de Llobregat, Spain
Tri-Service Genaral Hospital — Neihu District, Taiwan
Taipei Medical University Shuang Ho Hospital — New Taipei City, Taiwan
Chung Shan Medical University Hospital — Taichung, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan

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