Patients With Multiple SclerosisNCT05382195
Clinical Correlates of Psychiatric Comorbidities in Patients With Multiple Sclerosis
An observational study of Patients With Multiple Sclerosis, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients With Multiple Sclerosis
- What is being tested?
- hospital anxiety and depression scale
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Feb 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients with multiple sclerosis
Who may be able to join
- 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
Who cannot join
- Any patient with the following will be excluded from the study
- diagnosis of m.s is not definite
- vitally un stable
- refused consent
Trial locations and contacts
1 site in 1 country.
hazim k ibraheem, professor contact
About this study
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.
Read more
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 (
- Conditions
- Patients With Multiple Sclerosis
- Being tested
- hospital anxiety and depression scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hospital anxiety and depression scaleOther
Also called multiple sclerosis quality of life 54 intrument
questionare on patients with multiple sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
depression in patients with multiple sclerosis
hospital anxiety and depression scale a questionaire of depression from 0 to 21
Measured: 8 months
anxiety in patients with multiple sclerosis
hospital anxiety and depression scale a questionaire of anxiety from 0to 21
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients With Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mamdouh Ramadan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382195
- Sponsor's protocol ID
- Soh-Med-22-05-06
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25623244Wu 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.
PubMed 18236703Papuc 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.
PubMed 22137087Feinstein A. The neuropsychiatry of multiple sclerosis. Can J Psychiatry. 2004 Mar;49(3):157-63. doi: 10.1177/070674370404900302.
PubMed 15101497
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Correlates of Psychiatric Comorbidities in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05382195
- Acronym / sponsor ID
- Soh-Med-22-05-06
- Conditions
- Patients With Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 19 May 2022 (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.
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 (
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with multiple sclerosis
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Any patient with the following will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hospital anxiety and depression scaleAlso: multiple sclerosis quality of life 54 intrumentquestionare on patients with multiple sclerosis | Other | – |
Primary outcome
depression in patients with multiple sclerosis
Time frame: 8 months
hospital anxiety and depression scale a questionaire of depression from 0 to 21
anxiety in patients with multiple sclerosis
Time frame: 8 months
hospital anxiety and depression scale a questionaire of anxiety from 0to 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 25623244Marrie 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.
- Background: PubMed 18236703Wu 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.
- Background: PubMed 22137087Papuc 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.
- Background: PubMed 15101497Feinstein A. The neuropsychiatry of multiple sclerosis. Can J Psychiatry. 2004 Mar;49(3):157-63. doi: 10.1177/070674370404900302.
- Individual participant dataSharing planned: Undecided
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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.
hazim k ibraheem, professor contact
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 Patients With Multiple Sclerosis, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 May 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa m Ramadan, resident doctor (01092611449, esraa011043@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depression in patients with multiple sclerosis (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05382195, which also lists 4 linked publications.
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 19 May 2022.