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Ketamine maintenance treatment for depression: A multicenter open-label randomized controlled trial

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521330-29-00
Acronym
PreKET
Enrollment
230
Registered
2025-11-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression Disorder (MDD)

Brief summary

• Time-to-relapse after induction phase assessed by clinician rated MADRS between all 3 treatment arms, • Time-to-relapse after the last ketamine infusion assessed by clinician rated MADRS between all three treatment arms

Detailed description

• Assess frequency, severity and duration of ARs/SARs through clinical interview, observation, SCI-2 SF, DLCQ and PreKET symptom checklist, patient chart review, spontaneously reported adverse events from signing the ICF to Final visit.

Interventions

DRUGKETAMINE HYDROCHLORIDE

Sponsors

Ostfold Hospital Trust
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• Time-to-relapse after induction phase assessed by clinician rated MADRS between all 3 treatment arms, • Time-to-relapse after the last ketamine infusion assessed by clinician rated MADRS between all three treatment arms

Secondary

MeasureTime frame
• Assess frequency, severity and duration of ARs/SARs through clinical interview, observation, SCI-2 SF, DLCQ and PreKET symptom checklist, patient chart review, spontaneously reported adverse events from signing the ICF to Final visit.

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026