- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02774980
Cognitive Markers of Response to Treatment in Resistant Depression (DEP-ICOR)
Patients with depression are frequently treatment resistant. Clinical manifestations of depression are various, but cognitive dysfunctions are commonly present. Many factors are involved in treatment resistance. As no biological marker is available, clinical markers could be considered in predicting response to antidepressive treatment.
The aim of this study is to investigate the relation between the cognitive changes and the remission of depressive symptoms in patients with recurrent depression (Stage 2 of Thase and Rush classification).
To explore the dynamics of cognitive dimension associated to clinical and functional remission, the investigators will observe neurocognitive functioning before and after introducing a new antidepressive therapy.
Studieoversikt
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Nice, Frankrike, 06000
- Rekruttering
- Hôpital Pasteur
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Ta kontakt med:
- Nelly Darmon
- Telefonnummer: :+33 4 92 03 81 06
- E-post: darmon.n@chu-nice.fr
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Ta kontakt med:
- Michel Benoit, MD
- Telefonnummer: :+33 4 92 03 87 75
- E-post: benoit.m@chu-nice.fr
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Hovedetterforsker:
- Nelly Darmon
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Underetterforsker:
- Michel Benoit, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients will be aged from 40 to 70, with a major depressive episode diagnosis with a 2 stage degree of resistance.
Exclusion Criteria:
- Patients with major depressive episode during more of 12 months
- Alzheimer dementia or related disease (CIM 10)
- Score Hamilton Depression Rating Scale (HDRS) < 18
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Clinic assessments: Score BDI - II
Tidsramme: Change from the baseline score BDI-II at 12 months after introducing the new therapy
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The investigators will conduct clinical assessments.
A baseline will be drawn in the acute phase (V1) before modifying the antidepressive therapy; 2 weeks after treatment change, patient will be clinically assessed by his psychiatrist.
A complete assessment will be done 6 months and 12 months after introducing the new therapy.
|
Change from the baseline score BDI-II at 12 months after introducing the new therapy
|
Functional assessments : Score Sheehan Disability Scale (SDS)
Tidsramme: Change from the baseline Score Sheehan Disability Scale (SDS) at 12 months after introducing the new therapy
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The investigators will conduct functional assessments.
A baseline will be drawn in the acute phase (V1) before modifying the antidepressive therapy; 2 weeks after treatment change, patient will be functional assessed by his psychiatrist.
A complete assessment will be done 6 months and 12 months after introducing the new therapy.
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Change from the baseline Score Sheehan Disability Scale (SDS) at 12 months after introducing the new therapy
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Neuropsychologic assessments: M.M.S.E. (Mini Mental Score Evaluation)
Tidsramme: Change from the baseline Score M.M.S.E. (Mini Mental Score Evaluation) at 12 months after introducing the new therapy
|
The investigators will conduct neuropsychologic assessments.
A baseline will be drawn in the acute phase (V1) before modifying the antidepressive therapy; A complete assessment will be done 6 months and 12 months after introducing the new therapy.
|
Change from the baseline Score M.M.S.E. (Mini Mental Score Evaluation) at 12 months after introducing the new therapy
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Nelly Darmon, CHU of Nice
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14-AOI-07
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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