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Could a ketamine combo lift depression in the seriously ill?

NCT ID NCT02783430

Symptom relief Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a single dose of ketamine plus daily milnacipran can reduce depression in people with severe, progressive diseases. 42 participants in palliative care were split into two groups: one received the drug combo, the other a placebo plus milnacipran. The goal was to see if depression scores improved after 15 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketamine and milnacipran
What this could lead to
If it works, this could offer a new way to quickly ease severe depression in people with serious, progressive illnesses.
What could go wrong
This is a small, early-phase trial with only 42 participants, so results may not apply to everyone. The combination also carries risks like side effects from ketamine.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

42 people

The number who actually took part.

Started

Sep 2016

Finished

Mar 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression

Contacts and locations

Locations

  • C.H de Roubaix

    Roubaix, France

  • Centre Hospitalier de Valenciennes

    Valenciennes, France

  • Ch Calais

    Calais, France

  • Ch Ghpso Senlis

    Senlis, France

  • Ch Tourcoing

    Tourcoing, France

  • Chu Amiens Picardie

    Amiens, France

  • Groupt Hopitaux Instit Catho de Lille - Lomme

    Lomme, France

  • Maison Medicale Jean Xxiii - Lille

    Lille, 59037, France

  • University Hospital,

    Lille, France

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