NCT06652308

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 16, 2024

Last Update Submit

October 20, 2024

Conditions

Keywords

Multiple SclerosisMood DisordersUnipolar DepressionMental Health

Outcome Measures

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.

    6-year assessment (from diagnosis of MS).

Study Arms (1)

Multiple Sclerosis Patients with Mood Disorders

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong University

Jinan, China

Location

MeSH Terms

Conditions

Multiple SclerosisDepressive DisorderBipolar DisorderMood DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMental DisordersBipolar and Related DisordersPersonal SatisfactionBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 22, 2024

Study Start

July 1, 2024

Primary Completion

August 30, 2024

Study Completion

September 30, 2024

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations