Intranasal Esketamine Against Depression. A real world clinical treatment Cohort-Study in the Netherlands (INESKAD)

Study identification

• EU PAS number:
  EUPAS1000000892
• Study ID:
  1000000892
• Official title and acronym:
  Intranasal Esketamine Against Depression. A real world clinical treatment Cohort-Study in the Netherlands (INESKAD)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  Rationale: Intranasal esketamine is a new antidepressant drug with an alternative mechanism of action than routinely used antidepressants. Experience with esketamine especially in more severely treatment resistant depressed (TRD) patients is limited but needed in terms of real-world effectiveness and acceptability.; Objective: To collect and pool pseudoanonymised short- and long-term effectiveness and acceptability data for the treatment with intranasal esketamine in TRD-patients treated across all esketamine treatment centres in the Netherlands.; ; Study design: unblinded, naturalistic cohort study of patients who are treated with intranasal esketamine.; Study population: All patients with treatment resistant depression (TRD; defined as non-responsive to ≥2 antidepressant trials used at adequate dosages for ≥6 weeks), aged ≥18 years, clinically eligible for treatment with esketamine nasal spray.; ; Intervention: Open-label esketamine intranasal spray at 28-84mg/session twice weekly for 4 weeks (as addition to an antidepressant). Treatment responders will enter a Continuation (maintenance) Phase with 4 weeks weekly and thereafter -if possible- lower frequency of administration.; ; Main study parameters/endpoints: Primary outcome: change in MADRS-score relative to baseline. Secondary outcomes: change in IDS-SR-score relative to baseline; Quality of life and Daily functioning, adverse effects (KSET), cost-effectiveness and treatment discontinuations. We will measure behaviour on the Pavlovian instrumental transfer (PIT) task before and after 4 weeks of treatment. ; Nature and extent of the burden and risks associated with participation, benefit and group relatedness: as a potential alternative treatment for TRD, patients might benefit from this treatment. As long as the manufacturer’s precautions are followed there is minimal risk involved in this treatment. In this project no additional interventions or extra measurements will be performed apart from clinical assessments and
• Study status:
  Ongoing

Research institutions and networks

Institutions

Radboud university medical center (Radboudumc)

Netherlands

University Medical Center Utrecht (UMCU)

Netherlands

Amsterdam UMC

Leiden University Medical Centre (LUMC)

GGZ Drenthe, ApareeGGZ, UMCG, Elisabeth Tweesteden Ziekenhuis, Maxima Medisch Centrum Eindhoven, Mondriaan / PsyQ Maastricht, GGZ Delfland, Antonius ziekenhuis Nieuwegein, Parnassia Psy-Q Den Haag, Parnassia Antes, Parnassia Noord-Holland Castricum, Synaeda/GGZ Friesland, Vincent van Gogh, ProPersona, GGNet, GGZ Centraal, Reinier v Arkel, Amphia, Emergis, Rivierduinen, GGZ Noord-Holland Noord, Lentis, Spaarne gasthuis, Altrecht, Isala, Rivierenland, Ziekenhuis Groep Twente, Gelre Ziekenhuis, GGz InGeest

Networks

Esketamine Nasal spray Consortium - Netherlands (ENC-NL)

Study timelines

Date when funding contract was signed

Actual:01/01/2020

Study start date

Actual:01/01/2020

Date of final study report

Planned:31/12/2030

Sources of funding

Other

More details on funding

ENC-NL has been funded through in-kind contributions of participating centers regarding their staff to participate in the consortium/Network.
ENC-NL has received support from J&J by two unrestricted Educational Grants (July 2023-2024 and 2025-2026).

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Link to ENC-NL website (in Dutch)