Multiple Sclerosis (MS)MSMDNCT06652308
Mood Disorders in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis (MS) and Unipolar Depression, run by Islamic Azad University, Sanandaj at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis (MS), Unipolar Depression, Bipolar Disorder
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Sep 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Multiple Sclerosis, Mood Disorders, Unipolar Depression, Mental Health
- Medical subject headings
- Multiple Sclerosis, Depressive Disorder, Bipolar Disorder, Mood Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis Patients with Mood Disorders | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-year Frequency of Mood Disorders
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.
Measured: 6-year assessment (from diagnosis of MS).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Jul 2024
- Primary completion30 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaghayegh Radmehr, Islamic Azad University, Sanandaj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652308
- Sponsor's protocol ID
- MSMood2024-SDU
- Acronym
- MSMD
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Unipolar and Bipolar Mood Disorders in Patients with Multiple Sclerosis: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06652308
- Acronym / sponsor ID
- MSMD / MSMood2024-SDU
- Keywords
- Multiple Sclerosis, Mood Disorders, Unipolar Depression, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 22 Oct 2024 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis Patients with Mood Disorders | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6-year Frequency of Mood Disorders
Time frame: 6-year assessment (from diagnosis of MS).
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.
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 22 Oct 2024.
- Individual participant dataSharing planned: No
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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 Multiple Sclerosis (MS) and Unipolar Depression, run by Islamic Azad University, Sanandaj at 1 site in China.
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 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 22 Oct 2024. 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 China. 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?
6-year Frequency of Mood Disorders (time frame: 6-year assessment (from diagnosis of MS).). 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 22 Oct 2024; AzTrials last refreshed its copy on 28 Oct 2026.