Suicidal BehaviorNCT07145840
Suicidal Behavior Among Schizophrenic Patients
An observational study of Suicidal Behavior and Schizophrenic Patients, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to; - 1. Study suicidal behavior among sample of schizophrenic patients. 2. Study relation between schizophrenic symptoms and suicidal behavior. 3. Study the relation of mood symptoms in schizophrenic patients and suicidal behavior. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Suicidal Behavior, Schizophrenic Patients
- What is being tested?
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2022to 30 Mar 2023
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This cross-sectional study was carried out on patients diagnosed with schizophrenia recruited from inpatient and outpatient services of the Department of Neuropsychiatry and Center of Psychiatry, Neurology, Tanta University Hospitals, Egypt.
Who may be able to join
- Age between 18 and 60.
- Both females and males will be included.
- All patients should meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia.
Who cannot join
- Any neurological disorder.
- Past history of head trauma.
- Medical or autoimmune disorders.
- Other psychiatric disorders e. g. bipolar disorders, post-traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), and anxiety.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Suicidal Behavior Among Schizophrenic Patients
This study aimed to; -
- Study suicidal behavior among sample of schizophrenic patients.
- Study relation between schizophrenic symptoms and suicidal behavior.
- Study the relation of mood symptoms in schizophrenic patients and suicidal behavior.
Read the detailed description
Suicide is a major public health concern. According to the World Health Organization (WHO), approximately one million people die by suicide each year worldwide. This statistic means that every 40 seconds, someone dies by suicide somewhere on the globe, with many more people making non-lethal suicide attempts. It has been suggested that the number of individuals who attempt suicide without causing death is about 10-15 times the number of those who die by suicide.
Schizophrenia is a severe psychiatric disorder characterized by cognitive impairment and behavioral dysfunction. Patients with schizophrenia are at an elevated risk of self-harm, suicide, and all-cause mortality, which results in a reduction of life expectancy of up to 20 years compared with the general population.
Suicide risk in schizophrenia is notably high, and early detection depends on recognizing and evaluating clinical manifestations of depression, despair, and hopelessness, as well as the nature and severity of the psychotic experience, particularly in recently diagnosed patients with higher cognitive function and educational backgrounds.
There is a lack of studies on suicidal behaviors in schizophrenic patients in Arab countries. A study on overall suicidality in Arab countries reported a lifetime suicide attempt rate of 0.72%-6.3% and a suicide ideation rate of 2.09%-13.9%. More research is needed in this area due to the societal and economic costs of suicidal behavior in schizophrenic patients. This issue is a high priority for public health. Several trials have aimed to identify valid predictors of suicide risk. These predictors could not only help reduce the mortality associated with suicidality but also enable a more rational allocation of resources for treatment. Previous suicide attempts, depressive symptoms, hopelessness, and akathisia have been identified as reliable predictors of suicidal behavior.
- Conditions
- Suicidal Behavior, Schizophrenic Patients
- Being tested
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)Other
Psychiatric interview for diagnosis of schizophrenia by SCID 5 (American Psychiatric Association, 2015), The Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) is a semi structured interview guide for making the major DSM-5 diagnoses using the chapter of schizophrenia spectrum
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with schizophrenia. They had a current history of suicide ideation or attempt. Receives: Other: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) | |
| Group B | Patients with schizophrenia without any history of neither suicide ideation nor attempt. Receives: Other: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Suicidal Ideation
Assessed using the Arabic version of the Beck Scale for Suicide Ideation (BSS), which includes 21 statement groups rated on a 3-point scale. The total score ranges from 0 to 38, with higher scores indicating more severe suicidal ideation.
Measured: Within 1 week prior to assessment
Secondary outcomes (2)
Severity of Schizophrenia Symptoms
Measured using the Positive and Negative Syndrome Scale (PANSS), which assesses positive, negative, and general psychopathology symptoms. Higher scores reflect greater symptom severity.
Measured: Within 7 days
Severity of Depressive Symptoms
Measured using the Arabic version of the Hamilton Depression Rating Scale (HDRS-17). Total scores classify depression as mild, moderate, severe, or very severe.
Measured: Within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start30 Apr 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal BehaviorStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asmaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145840
- Sponsor's protocol ID
- 35394/4/22
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Suicidal Behavior Among Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT07145840
- Acronym / sponsor ID
- 35394/4/22
- Conditions
- Suicidal Behavior, Schizophrenic Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 28 Aug 2025 (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.
This study aimed to; -
- Study suicidal behavior among sample of schizophrenic patients.
- Study relation between schizophrenic symptoms and suicidal behavior.
- Study the relation of mood symptoms in schizophrenic patients and suicidal behavior.
Detailed description
Suicide is a major public health concern. According to the World Health Organization (WHO), approximately one million people die by suicide each year worldwide. This statistic means that every 40 seconds, someone dies by suicide somewhere on the globe, with many more people making non-lethal suicide attempts. It has been suggested that the number of individuals who attempt suicide without causing death is about 10-15 times the number of those who die by suicide.
Schizophrenia is a severe psychiatric disorder characterized by cognitive impairment and behavioral dysfunction. Patients with schizophrenia are at an elevated risk of self-harm, suicide, and all-cause mortality, which results in a reduction of life expectancy of up to 20 years compared with the general population.
Suicide risk in schizophrenia is notably high, and early detection depends on recognizing and evaluating clinical manifestations of depression, despair, and hopelessness, as well as the nature and severity of the psychotic experience, particularly in recently diagnosed patients with higher cognitive function and educational backgrounds.
There is a lack of studies on suicidal behaviors in schizophrenic patients in Arab countries. A study on overall suicidality in Arab countries reported a lifetime suicide attempt rate of 0.72%-6.3% and a suicide ideation rate of 2.09%-13.9%. More research is needed in this area due to the societal and economic costs of suicidal behavior in schizophrenic patients. This issue is a high priority for public health. Several trials have aimed to identify valid predictors of suicide risk. These predictors could not only help reduce the mortality associated with suicidality but also enable a more rational allocation of resources for treatment. Previous suicide attempts, depressive symptoms, hopelessness, and akathisia have been identified as reliable predictors of suicidal behavior.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)Patients with schizophrenia. They had a current history of suicide ideation or attempt. |
| Group B | – | Other: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)Patients with schizophrenia without any history of neither suicide ideation nor attempt. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This cross-sectional study was carried out on patients diagnosed with schizophrenia recruited from inpatient and outpatient services of the Department of Neuropsychiatry and Center of Psychiatry, Neurology, Tanta University Hospitals, Egypt.
Key inclusion criteria (3 listed)
- Age between 18 and 60.
- Both females and males will be included.
- All patients should meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia.
Key exclusion criteria (5 listed)
- Any neurological disorder.
- Past history of head trauma.
- Medical or autoimmune disorders.
- Other psychiatric disorders e. g. bipolar disorders, post-traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), and anxiety.
- Pregnancy.
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 |
|---|---|---|
| Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)Psychiatric interview for diagnosis of schizophrenia by SCID 5 (American Psychiatric Association, 2015), The Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) is a semi structured interview guide for making the major DSM-5 diagnoses using the chapter of schizophrenia spectrum | Other | Group A, Group B |
Primary outcome
Severity of Suicidal Ideation
Time frame: Within 1 week prior to assessment
Assessed using the Arabic version of the Beck Scale for Suicide Ideation (BSS), which includes 21 statement groups rated on a 3-point scale. The total score ranges from 0 to 38, with higher scores indicating more severe suicidal ideation.
2 secondary outcomes
Severity of Schizophrenia Symptoms
Time frame: Within 7 days
Severity of Depressive Symptoms
Time frame: Within 7 days
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 28 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicidal Behavior and Schizophrenic Patients, run by Tanta 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 3 inclusion and 5 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 28 Aug 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Severity of Suicidal Ideation (time frame: Within 1 week prior to assessment). 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 28 Aug 2025.