Depression, AnxietyPhase 4NCT06060210
Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion
A Phase 4 study testing normal Saline and Ketamine in people with Depression, Anxiety, run by Benha University at 1 site in Egypt.
Trial summary
Postoperative depression is a perioperative psychological complication that severely affects patient recovery and quality of life. In extreme cases, it may lead to suicidal behavior. Postoperative depression can be seen in various surgical operations . Read more about this study
- Who is it for?
- Ages 20 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- normal Saline and Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Oct 2023to 1 Nov 2025
- Phase
- Phase 4
- 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 20 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients of both sex
- with an age range from 20 to 44 years old
- having moderate to severe depressive symptoms
- an expected hospital stay of no less than 7 days
Who cannot join
- history of epilepsy
- major depressive disorder patients
- drug abuse
- history of allergy to the research drug
- heart rate > 120 beats per minute
- systolic blood pressure > 180 mmHg
Show all 11Show fewer
- heart failure
- renal or liver dysfunction
- patients who cannot cooperate to complete psychiatric assessments
- pregnant or breast-feeding women
- patients who refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion. A Randomized Double-blind Controlled Trial.
Postoperative depression is a perioperative psychological complication that severely affects patient recovery and quality of life. In extreme cases, it may lead to suicidal behavior. Postoperative depression can be seen in various surgical operations .
High rates of anxiety and depression have been reported in cohorts of patients with IIH, though it is not clear whether there is any direct relationship. Worse outcomes in terms of disability level and symptom resolution have been observed in IIH patients who have a known co-existing psychiatric illness compared to those who do not .
Read the detailed description
Postoperative depression is a perioperative psychological complication that severely affects patient recovery and quality of life. In extreme cases, it may lead to suicidal behavior. Postoperative depression can be seen in various surgical operations.
Idiopathic intracranial hypertension (IIH) is the most common cause of papilledema and is typically seen in young women with elevated body mass index. The prevalence of IIH has been increasing in recent years, in parallel with climbing rates of obesity .
High rates of anxiety and depression have been reported in cohorts of patients with IIH, though it is not clear whether there is any direct relationship. Worse outcomes in terms of disability level and symptom resolution have been observed in IIH patients who have a known co-existing psychiatric illness compared to those who do not .
The use of lumbo-peritoneal (LP) shunts has been well documented as a treatment modality for patients with idiopathic intracranial hypertension (IIH). There are a number of advantages to LP shunts when compared with other treatment modalities for IIH, such as stereotactic ventriculo-peritoneal shunts (VP) and optic nerve sheath fenestrations (ONSF). LP shunts avoid intracranial risks, such as cerebral hemorrhage, seizures, and shunt malposition.
Over the past decade, it has been provoked a single administration of ketamine elicits fast (in as little as half an hour) and sustained antidepressant effects both in human and animal models of depression. There are some potential mechanisms of antidepressant actions of ketamine. MK-801, a noncompetitive NMDA receptor antagonist, produced antidepressant-like actions in the animal model of depression . Ketamine can also increase hippocampal brain-derived neurotrophic factor levels, which may be important for producing a rapid onset of antidepressant action .A recent study found ketamine could quickly elevate mood by blocking NMDAR receptor-dependent bursting activity of the lateral habenula neurons to disinhibit downstream monoaminergic reward centers and provide a framework for developing new rapid-acting antidepressants .
Accordingly, we hypothesized that intraoperative ketamine can reduce the post operative depressive symptoms after theco-peritoneal shunt insertion.
- Conditions
- Depression, Anxiety
- Being tested
- normal Saline, Ketamine
- Keywords
- ketamine, perioperative depression, lumboperitoneal shunt
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal SalineDrug
50-ml Saline
KetamineDrug
Also called katalar
50-ml volumes, and the ketamine concentration is 1 mg/ml
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | 50-ml volume of normal saline Receives: Drug: normal Saline |
| Group B | Active comparator | 50-ml volumes, and the ketamine concentration is 1 mg/ml Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of response to treating postoperative depression
defined as a relative reduction of more than 50% from the baseline 10-item MADRS score
Measured: at 3 postoperative days
Secondary outcomes (3)
The remission rate
defined as an absolute value of MADRS score of no more than 10
Measured: at 1 and 3 days after the administration of ketamine.
The incidence of severe pain
From 0 to 10 (0 no pain , 10 very sever pain)
Measured: within the first 48 hours postoperatively
The quality of life
a scale ranging from 100-0, where 100 is labeled 'Perfect quality of life,' and 0 is labeled 'Might as well be dead'.
Measured: within 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start29 Oct 2023
- Primary completion1 Sep 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmed Abdel Fatah, Benha University
- Investigators
- Fatma Ah Abdelfatah, MD, Principal investigator, banha faculity of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060210
- Sponsor's protocol ID
- RC 12-9-2023
- Status last verified
- Dec 2024
- First submitted
- 24 Sep 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion. A Randomized Double-blind Controlled Trial.
- ClinicalTrials.gov ID
- NCT06060210
- Acronym / sponsor ID
- RC 12-9-2023
- Conditions
- Depression, Anxiety
- Keywords
- ketamine, perioperative depression, lumboperitoneal shunt
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 29 Oct 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 29 Sep 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.
Postoperative depression is a perioperative psychological complication that severely affects patient recovery and quality of life. In extreme cases, it may lead to suicidal behavior. Postoperative depression can be seen in various surgical operations .
High rates of anxiety and depression have been reported in cohorts of patients with IIH, though it is not clear whether there is any direct relationship. Worse outcomes in terms of disability level and symptom resolution have been observed in IIH patients who have a known co-existing psychiatric illness compared to those who do not .
Detailed description
Postoperative depression is a perioperative psychological complication that severely affects patient recovery and quality of life. In extreme cases, it may lead to suicidal behavior. Postoperative depression can be seen in various surgical operations.
Idiopathic intracranial hypertension (IIH) is the most common cause of papilledema and is typically seen in young women with elevated body mass index. The prevalence of IIH has been increasing in recent years, in parallel with climbing rates of obesity .
High rates of anxiety and depression have been reported in cohorts of patients with IIH, though it is not clear whether there is any direct relationship. Worse outcomes in terms of disability level and symptom resolution have been observed in IIH patients who have a known co-existing psychiatric illness compared to those who do not .
The use of lumbo-peritoneal (LP) shunts has been well documented as a treatment modality for patients with idiopathic intracranial hypertension (IIH). There are a number of advantages to LP shunts when compared with other treatment modalities for IIH, such as stereotactic ventriculo-peritoneal shunts (VP) and optic nerve sheath fenestrations (ONSF). LP shunts avoid intracranial risks, such as cerebral hemorrhage, seizures, and shunt malposition.
Over the past decade, it has been provoked a single administration of ketamine elicits fast (in as little as half an hour) and sustained antidepressant effects both in human and animal models of depression. There are some potential mechanisms of antidepressant actions of ketamine. MK-801, a noncompetitive NMDA receptor antagonist, produced antidepressant-like actions in the animal model of depression . Ketamine can also increase hippocampal brain-derived neurotrophic factor levels, which may be important for producing a rapid onset of antidepressant action .A recent study found ketamine could quickly elevate mood by blocking NMDAR receptor-dependent bursting activity of the lateral habenula neurons to disinhibit downstream monoaminergic reward centers and provide a framework for developing new rapid-acting antidepressants .
Accordingly, we hypothesized that intraoperative ketamine can reduce the post operative depressive symptoms after theco-peritoneal shunt insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: normal Saline50-ml volume of normal saline |
| Group B | Active comparator | Drug: Ketamine50-ml volumes, and the ketamine concentration is 1 mg/ml |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients of both sex
- with an age range from 20 to 44 years old
- having moderate to severe depressive symptoms
- an expected hospital stay of no less than 7 days
Key exclusion criteria (11 listed)
- history of epilepsy
- major depressive disorder patients
- drug abuse
- history of allergy to the research drug
- heart rate > 120 beats per minute
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 |
|---|---|---|
| normal Saline50-ml Saline | Drug | Group A |
| KetamineAlso: katalar50-ml volumes, and the ketamine concentration is 1 mg/ml | Drug | Group B |
Primary outcome
the rate of response to treating postoperative depression
Time frame: at 3 postoperative days
defined as a relative reduction of more than 50% from the baseline 10-item MADRS score
3 secondary outcomes
The remission rate
Time frame: at 1 and 3 days after the administration of ketamine.
The incidence of severe pain
Time frame: within the first 48 hours postoperatively
The quality of life
Time frame: within 7 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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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.
Fatma Ah Abdelfatah, MD principal investigator
banha faculity of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing normal Saline and Ketamine in people with Depression, Anxiety, run by Benha University at 1 site in Egypt.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the rate of response to treating postoperative depression (time frame: at 3 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.