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CompletedPhase 2 / Phase 3

Ketamine and Postoperative Depressive Symptom-PASSION

NCT03086148 · Beijing Tiantan Hospital

Closed to entry
Status
Not accepting participants
Phase 2 / Phase 3
Phase
84
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Perioperative depression symptom (PDS) is one of the common mental comorbidity, and influences the clinical outcomes and prognosis. However, there is no rapid acting treatment to deal with it during the limited hospital stay. This study aims to determine whether ketamine could improve the depressive symptom of peirioperative patients. It will also examine the safety for administrating ketamine as an antidepressant intraoperatively. Meanwhile, it will show if ketamine could improve anxiety, postoperative pain or delirium. This trial also will bring great concerns on patients with perioperative mental health and explore the measures to improve their psycho-related prognosis.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Response rate

    Measured over Postoperative 3 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Brain tumor located supratentorial area and need to receive elective craniotomy; 2. Moderate to severe depressive symptom measured by the qualified psychiatric doctors. 3. Ages between 18 and 65 years old. 4. American Society of Anesthesiologists physical status I-III Exclusion Criteria: 1. History of epilepsy; 2. Major depression disorder patients undergoing antidepressive therapy within 2 weeks; 3 Psychiatric illness; 4 Drug abuse; 5 History of allergy to the research drug; 6 Tumor located in the Wernick area, Broca area or the frontal pole; 7 Hyperthyroidism; 8 Patients can not cooperate with investigators on psychiatric assessments; 9 Pregnant or breast-feeding woman; 10 refuse to sign inform consent.

Where

1 study site

FacilityCityRegionCountry
Beijing TianTan HospitalBeijingChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03086148 on ClinicalTrials.gov →

Last updated in the registry 2020-07-07. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits