- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06652308
Mood Disorders in Multiple Sclerosis Patients (MSMD)
Frequency of Unipolar and Bipolar Mood Disorders in Patients with Multiple Sclerosis: a Retrospective Cohort Study
This study investigates the frequency of unipolar and bipolar mood disorders in patients with multiple sclerosis. MS is a chronic condition that affects the central nervous system, and previous research suggests that mood disorders, such as depression and bipolar disorder, may occur more frequently in MS patients compared to the general population.
A retrospective analysis of 85 patients diagnosed with MS was conducted, evaluating lifetime experiences with mood disorders using structured clinical interviews. The goal is to better understand the prevalence of these mood disorders and to raise awareness of the importance of mental health care in patients with MS. The findings highlight that mood disorders, particularly bipolar disorder, are more common in MS patients than previously thought. This information can help healthcare providers improve screening, diagnosis, and treatment for MS patients suffering from mood disorders.
Study Overview
Status
Detailed Description
This study is a retrospective cohort analysis designed to examine the lifetime prevalence of unipolar and bipolar mood disorders in patients with multiple sclerosis. MS is a chronic, demyelinating condition of the central nervous system that leads to varying degrees of neurological impairment. Previous studies have shown that mood disorders, particularly depression and bipolar disorder, are more prevalent in patients with MS than in the general population.
Data from 85 patients (45 females and 40 males) diagnosed with MS were analyzed, focusing on psychiatric history through structured clinical interviews. The study evaluated the presence of mood disorders, including major depressive disorder, bipolar disorder types I and II, dysthymia, and unclassified mood disorders. Data were collected using DSM-IV criteria to ensure consistency in diagnosis.
The results demonstrate that mood disorders, especially bipolar disorder, are more frequent than previously reported in this patient population. These findings underscore the need for improved mental health screening and treatment for MS patients, as managing psychiatric comorbidities can significantly enhance overall quality of life. The study emphasizes the importance of integrating psychiatric care into routine MS management.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jinan, China
- Shandong University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population consists of 85 patients diagnosed with multiple sclerosis who were selected through simple random sampling from the Iranian MS Association. The cohort includes:
Gender Distribution:
45 females (52.9%) 40 males (47.1%)
Age Range:
Participants are aged between 18 and 65 years. The average age of participants is approximately 5.47 years (please verify if this is correct as it seems like it might be a typo).
Geographic Location:
All participants reside in Tehran, Iran.
Description
Inclusion Criteria:
- Diagnosis of Multiple Sclerosis: Participants must have a confirmed diagnosis of multiple sclerosis (MS) by a qualified neurologist.
- Age Range: Participants must be between 18 and 65 years of age.
- Informed Consent: Participants must provide informed consent to participate in the study.
- Geographic Location: Participants must reside in Tehran, Iran.
Exclusion Criteria:
- Other Neurological Disorders: Individuals with a diagnosis of any other neurological disease (e.g., epilepsy, Parkinson's disease) will be excluded.
- Head Trauma: History of head trauma that resulted in impaired consciousness or memory loss.
- Seizures: A history of seizures that could affect mood.
- Substance Dependence: A history of substance dependence as per DSM-IV criteria.
- Other Physical Illnesses: Any systemic or physical diseases that could lead to mood symptoms.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Multiple Sclerosis Patients with Mood Disorders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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6-year Frequency of Mood Disorders
Time Frame: 6-year assessment (from diagnosis of MS).
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The primary outcome measure is the 6-year frequency of mood disorders (unipolar and bipolar) diagnosed in patients with multiple sclerosis (MS).
This will be evaluated using semi-structured clinical interviews based on DSM-IV criteria.
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6-year assessment (from diagnosis of MS).
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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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bipolar and Related Disorders
- Nervous System Diseases
- Mental Disorders
- Pathologic Processes
- Autoimmune Diseases
- Immune System Diseases
- Behavioral Symptoms
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Multiple Sclerosis
- Sclerosis
- Depression
- Depressive Disorder
- Bipolar Disorder
- Mood Disorders
Other Study ID Numbers
- MSMood2024-SDU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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