Anxiety-depressionEarly Phase 1NCT06073015

Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients

A Early Phase 1 study testing Esketamine in people with Anxiety-depression, run by Henan Provincial People's Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 8 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety-depression
What is being tested?: Esketamine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: No sites listed yet
Study dates: 10 Oct 2023to 10 Feb 2025
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

8 years ≤ age ≤17 years;
Patients who plan to undergo elective surgery under general anesthesia, and the operation time is ≥2h;
ASA grade I-II

Who cannot join

Patients expected to be admitted to ICU after surgery;
Patients who need to return to the ward with tracheal intubation after surgery;
Allergic to the active ingredients or excipients of isketamine hydrochloride injection;
Patients with severe consciousness disorder or mental system disease (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
Patients with congenital heart disease and severe developmental delay;
Patients with one of the following contraindications to esketamine :(a) patients at risk of a significant increase in blood pressure or intracranial pressure; (b) Patients with ocular hypertension (glaucoma) or penetrating ocular trauma; (c) Patients with poorly controlled or untreated hypertension (resting systolic blood pressure greater than 180 mmHg or resting diastolic blood pressure greater than 100 mmHg); (d) Untreated or undertreated hyperthyroidism;
Previous history of ketamine abuse or dependence, drug or alcohol dependence for more than 6 months, previous ketamine ineffective tests or adverse reactions.

About this study

This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 8-17 years old are selected as subjects. Esketamine is used as intervention before surgery, vital signs data, serum IL-6, CRP and other inflammatory indicators are collected during surgery, and the incidence and degree of anxiety and depression are evaluated after surgery. To determine the effect of esketamine on reducing anxiety and depression in adolescents after surgery, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after surgery.

Conditions: Anxiety-depression
Being tested: Esketamine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EsketamineDrug
Group S received a subanesthetic dose of esketamine 0.2mg/kg (2ml/50 mg) 5 minutes before the procedure began.

Study groups in NCT06073015
Study group	Role	What they receive
Experimental group	Experimental	Esketamine (0.25mg/kg) Receives: Drug: Esketamine
Control group	No intervention	the same volume of normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Anxiety and depression scale scores 1 month after surgery
Anxiety and depression scale scores 1 month after surgery
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 202310 Feb 2025

First posted10 Oct 2023
Study start10 Oct 2023 (estimated)
Primary completion10 Dec 2024 (estimated)
Study completion10 Feb 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anxiety-depressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06073015
Sponsor's protocol ID: henanLYH
Status last verified: Oct 2023
First submitted: 3 Oct 2023
Last updated: 10 Oct 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Anxiety-depression trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients
ClinicalTrials.gov ID: NCT06073015
Acronym / sponsor ID: henanLYH
Conditions: Anxiety-depression
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 200 participants (estimated)
Lead sponsor: Henan Provincial People's HospitalUniversity, hospital or other
Study start: 10 Oct 2023 (estimated)
Primary completion: 10 Dec 2024 (estimated)
Study completion: 10 Feb 2025 (estimated)
First posted: 10 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Drug: EsketamineEsketamine (0.25mg/kg)
Control group	No intervention	–the same volume of normal saline

Who may qualify

Ages: 8 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

8 years ≤ age ≤17 years;
Patients who plan to undergo elective surgery under general anesthesia, and the operation time is ≥2h;
ASA grade I-II

Key exclusion criteria (7 listed)

Patients expected to be admitted to ICU after surgery;
Patients who need to return to the ward with tracheal intubation after surgery;
Allergic to the active ingredients or excipients of isketamine hydrochloride injection;
Patients with severe consciousness disorder or mental system disease (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
Patients with congenital heart disease and severe developmental delay;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EsketamineGroup S received a subanesthetic dose of esketamine 0.2mg/kg (2ml/50 mg) 5 minutes before the procedure began.	Drug	Experimental group

Primary outcome

Anxiety and depression scale scores 1 month after surgery
Time frame: 1 month
Anxiety and depression scale scores 1 month after surgery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.

Related trials for Anxiety-depression

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Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Esketamine in people with Anxiety-depression, run by Henan Provincial People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety and depression scale scores 1 month after surgery (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06073015.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.