NCT05382195

Brief Summary

Many neuropsychiatric abnormalities associated with multiple sclerosis (MS). These may be broadly divided into 2 categories: disorders of mood, affect,and behavior and abnormalities affecting cognition. With respect to the former, theepidemiology, phenomenology, and theories of etiology are described for the syndromes ofdepression, bipolar disorder, euphoria, pathological laughing and crying, and psychosisattributable to MS. Finally,treatment pertaining to all these disorders is reviewed, with the observation thattranslational research has been found wanting when it comes to providing algorithms toguide clinicians. Guidelines derived from general psychiatry still largely apply, althoughthey may not always be most effective in patients with neurologic disorders. The importance of future research addressing this imbalance is emphasized, forneuropsychiatric sequel add significantly to the morbidity associated with MS.(1) The evolution of the neuropsychiatry of multiple sclerosis(MS), with a set sequence of events unfoldingoverthecourseofacenturyormore,providesahistoricalparadigmforotherneurologicdisorders.Accordingtotheparadigm,aclinically astute neurologist, whom posterity will treat kindly,first describes the neurologic (and occasionally, the psycho-logical) signs and symptomsthat cometo define the disorder. Over succeeding decades, the diagnostic criteria arerefined by further observation supplemented by data fromnew technologies. Mental state changes either pass with littlenoticeoraremissed.Acoupleofgenerationslatercomes belated recognition of prominent abnormalities in mentation-neuropsychiatryredux. . Invariably, the data reveal major psychiatric problems integral to the disease, and then, with fewexceptions, clinical research stops. Few double-blind,placebo-controlled treatment trials in neuropsychiatry provide an evidence-based approach to treating the newly discernedbehaviouralabnormalities. ThelifetimeprevalenceofmajordepressioninMS isapproximately 50% (2). A meta-analysis suggests that this is higherthan in other neurologic disorders (3) and, depending on thereferencepoint,is3to10 timestherateinthegeneral population (4). While the basic phenomenology of the MS depressive syndrome overlaps with that found in primarydepression, certain symptoms are more typical, while othersoccur less commonly. Thus, irritability, discouragement, andasenseoffrustration aremorelikelytoaccompanylowmoodthan are feelings of guilt and poor self-esteem (5). It is alsoimportanttorememberthatsymptomssuchasinsomnia,poorappetite,anddifficultieswithconcentrationandmemorymaybe equally attributable to depression or to MS. Depression is an important reason for so many MS patients'thoughtsofself-harm:suicidalintentoccursinapproximately30% of MS patients and is linked to the presence and severityof depression and social isolation (

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

May 15, 2022

Last Update Submit

May 15, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • depression in patients with multiple sclerosis

    hospital anxiety and depression scale a questionaire of depression from 0 to 21

    8 months

  • anxiety in patients with multiple sclerosis

    hospital anxiety and depression scale a questionaire of anxiety from 0to 21

    8 months

Interventions

questionare on patients with multiple sclerosis

Also known as: multiple sclerosis quality of life 54 intrument

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with multiple sclerosis

You may qualify if:

  • The diagnosis of MS will be established clinically from the history according to revised McDonald's criteria 2010 The following psychiatric disorders ;depression , anxiety fulfilling the diagnostic criteria according to DSM5 as regard therapy, in the out patient clinic of Neuropsychiatry at Sohag university hospital from 1-6-2022 to 1-2-2023

You may not qualify if:

  • Any patient with the following will be excluded from the study
  • diagnosis of m.s is not definite
  • vitally un stable
  • refused consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • Marrie RA, Cohen J, Stuve O, Trojano M, Sorensen PS, Reingold S, Cutter G, Reider N. A systematic review of the incidence and prevalence of comorbidity in multiple sclerosis: overview. Mult Scler. 2015 Mar;21(3):263-81. doi: 10.1177/1352458514564491. Epub 2015 Jan 26.

    PMID: 25623244BACKGROUND
  • Wu N, Minden SL, Hoaglin DC, Hadden L, Frankel D. Quality of life in people with multiple sclerosis: data from the Sonya Slifka Longitudinal Multiple Sclerosis Study. J Health Hum Serv Adm. 2007 Winter;30(3):233-67.

    PMID: 18236703BACKGROUND
  • Papuc E, Stelmasiak Z. Factors predicting quality of life in a group of Polish subjects with multiple sclerosis: accounting for functional state, socio-demographic and clinical factors. Clin Neurol Neurosurg. 2012 May;114(4):341-6. doi: 10.1016/j.clineuro.2011.11.012. Epub 2011 Dec 1.

    PMID: 22137087BACKGROUND
  • Feinstein A. The neuropsychiatry of multiple sclerosis. Can J Psychiatry. 2004 Mar;49(3):157-63. doi: 10.1177/070674370404900302.

    PMID: 15101497BACKGROUND

MeSH Terms

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Central Study Contacts

Esraa m Ramadan, resident doctor

CONTACT

hazim k ibraheem, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Neuropsyiatric department faculty of medicine sohag university

Study Record Dates

First Submitted

May 15, 2022

First Posted

May 19, 2022

Study Start

June 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations