- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07145840
- Original Trial
Suicidal Behavior Among Schizophrenic Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
Patients with schizophrenia.
They had a current history of suicide ideation or attempt.
|
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
|
|
Group B
Patients with schizophrenia without any history of neither suicide ideation nor attempt.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 1 week prior to assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of Schizophrenia Symptoms
Time Frame: Within 7 days
|
Measured using the Positive and Negative Syndrome Scale (PANSS), which assesses positive, negative, and general psychopathology symptoms.
Higher scores reflect greater symptom severity.
|
Within 7 days
|
|
Severity of Depressive Symptoms
Time Frame: Within 7 days
|
Measured using the Arabic version of the Hamilton Depression Rating Scale (HDRS-17).
Total scores classify depression as mild, moderate, severe, or very severe.
|
Within 7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 35394/4/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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