Clinical trial NCT06314204: Impact of Cannabis Consumption on the Course, Modalities of Hospitalization and the Short-term Prognosis of Inpatients Suffering From Psychotic Symptoms
Official title: Impact of Cannabis Consumption on the Course, Modalities of Hospitalization and the Short-term Prognosis of Inpatients Suffering From Psychotic Symptoms : Multicenter Comparative Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psychotic; Disorder, Cannabis
Keywords: cannabis-Timing-hospitalization-psychotic sympyomatology
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of this study will consist of patients over the age of 18 with trans-nosographic psychotic symptomatology (schizophrenia, schizoaffective disorder, mood disorder with psychotic characteristic, psychotic disorder induced by substances, brief psychotic disorder, schizophrenic disorder, delirious disorders), hospitalized in psychiatry, free care or under duress in the Hospitalization Units to Full-time (UHTP) EPS Ville-Evrard. This protocol also concerns protected adults. Forecasted number of patients: 200 patients.

Brief summary: Few studies have evaluated, in patients with symptomatology the impact of cannabis use on the duration of hospitalization and on short- and medium-term developments. The objective of this study will be to assess the impact of cannabis on the duration, the hospitalization and the short- and medium-term evolution of patients with psychotic symptoms and cannabis use. We hypothesize that these patients (in comparison with patients with psychotic symptomatology and not using cannabis) would be hospitalized more long, exposed to a higher risk of resistance to the usual therapeutics, would have a lack of therapeutic alliance and insight, relapses and hospitalizations more frequent, more marked negative symptoms and lower quality remission. They would also be more prone to impulsive and aggressive behaviour.

Detailed description: Several studies have reported that cannabis use worsen the prognosis of psychiatric pathologies in general and psychotic in particular.

Few or no studies have evaluated the impact of cannabis consumption on patients with psychotic symptoms during their hospitalization (duration, type of hospitalization, quality of relationship with staff hospital), and on the short-term prognosis.

The objective of this study will be to assess the impact of cannabis on the duration of the hospitalization and the short- and medium-term evolution of patients with a psychotic symptomatology and cannabis use. Making the hypothesis that these patients (compared to patients with symptomatology psychotic and not using cannabis) would be hospitalized longer, exposed at a higher risk of resistance to the usual therapies, to have a lack of alliance therapeutic and insight, relapses and more frequent hospitalizations and symptoms.

They would also be more likely to have lower quality. They would also be more likely to be impulsive, and have aggressive behaviours.

Eligibility criteria: Inclusion Criteria:

* Hospitalized in psychiatry regardless of the mode of hospitalization
* With or without protective measures (guardianship or curatorship)
* Presenting psychotic symptoms (schizophrenia, schizo affective disorder, thymic disorder with psychotic characteristic, psychotic disorder substance-induced, brief psychotic disorder, schizophrenic disorders, delirious disorders)
* Members of the social security system
* Enlightened information

Exclusion Criteria:

* Degenerative neurological pathologies or mental retardation
* Psychotic disorders secondary to generalized medical conditions(epilepsy, delirium tremens, tumors, etc.)
* Other psychiatric pathologies

Primary outcomes:
measure: PANSS: Positive and Negative Syndrom Scale
timeFrame: AT the beginning of the study, before any procedure, (T1)
measure: PANSS: Positive and Negative Syndrom Scale
timeFrame: Approximatively 2 or 3 weeks after T1,On the day of the discharge (T2)
measure: PANSS: Positive and Negative Syndrom Scale
timeFrame: 1 month after the discharge (T3)
measure: PANSS: Positive and Negative Syndrom Scale
timeFrame: 3 month after the discharge (T4)
measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form
timeFrame: AT the beginning of the study, before any procedure (T1)
measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form)
timeFrame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form)
timeFrame: one month after the discharge
measure: MCQ-SF :Marijuana Craving Questionnaire- Short Form)
timeFrame: three month after the discharge
measure: CGI: Clinical Global Impression
timeFrame: AT the beginning of the study, before any procedure (T1)
measure: CGI: Clinical Global Impression
timeFrame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
measure: CGI: Clinical Global Impression
timeFrame: one month after the discharge
measure: CGI: Clinical Global Impression
timeFrame: three month after the discharge
measure: MADRS: Montgomery Åsberg Depression Rating Scale
timeFrame: AT the beginning of the study, before any procedure (T1)
measure: MADRS: Montgomery Åsberg Depression Rating Scale
timeFrame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
measure: MADRS: Montgomery Åsberg Depression Rating Scale
timeFrame: one month after the discharge
measure: MADRS: Montgomery Åsberg Depression Rating Scale
timeFrame: Three month after the discharge
measure: PDS: Psychotic Depression Scale
timeFrame: AT the beginning of the study, before any procedure (T1)
measure: PDS: Psychotic Depression Scale
timeFrame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
measure: PDS: Psychotic Depression Scale
timeFrame: one month after the discharge
measure: PDS: Psychotic Depression Scale
timeFrame: Three month after the discharge
measure: YMRS: Young Mania Rating Scale
timeFrame: AT the beginning of the study, before any procedure (T1)
measure: YMRS: Young Mania Rating Scale
timeFrame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
measure: YMRS: Young Mania Rating Scale
timeFrame: one month after the discharge
measure: YMRS: Young Mania Rating Scale
timeFrame: Three month after the discharge
measure: CDS: Self-Consciousness Revised Scale
timeFrame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
measure: CTQ: Childhood Trauma Questionnaire
timeFrame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
measure: BFI: Big Five Inventory
timeFrame: Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Neuilly Sur Marne
country: France
facility: unité de recherche clinique de l'E.P.S de Ville Evrard
Study officials:
References: