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CompletedNCT06652308MSMDUpdated Oct 22, 2024

Mood Disorders in Multiple Sclerosis Patients

An observational study in Multiple Sclerosis (MS), Unipolar Depression and Bipolar Disorder, sponsored by Islamic Azad University, Sanandaj. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-22.

Sponsored by Islamic Azad University, Sanandaj · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
85
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Multiple Sclerosis (MS)
  • Unipolar Depression
  • Bipolar Disorder
  • Mood Disorders

Keywords

  • Multiple Sclerosis
  • Mood Disorders
  • Unipolar Depression
  • Mental Health
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 85 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Islamic Azad University, Sanandaj is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
85 participants (actual)
Patient registry
No

Groups and cohorts

  • Multiple Sclerosis Patients with Mood Disorders
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6-year assessment (from diagnosis of MS).

07

Study locations

1 site
  • Shandong University
    Jinan, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06652308
Lead sponsor
Islamic Azad University, Sanandaj
Responsible party
Shaghayegh Radmehr (Dr, Islamic Azad University, Sanandaj) — Principal investigator
First posted
Oct 22, 2024
Start date
Jul 1, 2024
Primary completion
Aug 30, 2024
Completion
Sep 30, 2024
Last update
Oct 22, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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