Impact of Cannabis Consumption on the Course, Modalities of Hospitalization and the Short-term Prognosis of Inpatients Suffering From Psychotic Symptoms

NCT06314204 | Recruiting

• 1 other identifier: 2015-A01222-47
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic; Disorder, Cannabis

Keywords

cannabis-Timing-hospitalization-psychotic sympyomatology

Outcome Measures

Primary Outcomes (27)

• PANSS: Positive and Negative Syndrom Scale

  This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.

  AT the beginning of the study, before any procedure, (T1)

• PANSS: Positive and Negative Syndrom Scale

  This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.

  Approximatively 2 or 3 weeks after T1,On the day of the discharge (T2)

• PANSS: Positive and Negative Syndrom Scale

  This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.

  1 month after the discharge (T3)

• PANSS: Positive and Negative Syndrom Scale

  This scale permit to assess the severity of schizophrenia.Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112. The total PANSS score is simply the sum of the sub scales.

  3 month after the discharge (T4)

• MCQ-SF :Marijuana Craving Questionnaire- Short Form

  The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.

  AT the beginning of the study, before any procedure (T1)

• MCQ-SF :Marijuana Craving Questionnaire- Short Form)

  The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.

  Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)

• MCQ-SF :Marijuana Craving Questionnaire- Short Form)

  The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.

  one month after the discharge

• MCQ-SF :Marijuana Craving Questionnaire- Short Form)

  The scale permit to determine the marijuana craving. The subscales exhibited low to moderate, positive intercorrelations and were significantly correlated with marijuana use history and a wide range of single-item measures of craving. Conclusions. Findings suggested that four specific constructs characterize craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.

  three month after the discharge

• CGI: Clinical Global Impression

  It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition. The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

  AT the beginning of the study, before any procedure (T1)

• CGI: Clinical Global Impression

  It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition. The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

  Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)

• CGI: Clinical Global Impression

  It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition. The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

  one month after the discharge

• CGI: Clinical Global Impression

  It is used with all patients, allowing the evaluation of the improvement of assessing the severity and change of the overall clinical condition. The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients Improvement scale The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

  three month after the discharge

• MADRS: Montgomery Åsberg Depression Rating Scale

  It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood. It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.

  AT the beginning of the study, before any procedure (T1)

• MADRS: Montgomery Åsberg Depression Rating Scale

  It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood. It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.

  Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)

• MADRS: Montgomery Åsberg Depression Rating Scale

  It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood. It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.

  one month after the discharge

• MADRS: Montgomery Åsberg Depression Rating Scale

  It is validated in France by Pellet and its collaborators in 1987. It allows to evaluate the modifications of mood. It has 10 psychic and somatic items (apparent sadness, sadness expressed, inner tension, insomnia, loss of appetite, difficulty concentrating, weariness, loss of feelings, pessimism and thoughts of suicide) sides from 0 to 6 according to the 6 degrees of severity and whose scores add up.

  Three month after the discharge

• PDS: Psychotic Depression Scale

  It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms. All items are scoring from 0 to 6: 0: nothing 2 :light 4: important 6: extreme

  AT the beginning of the study, before any procedure (T1)

• PDS: Psychotic Depression Scale

  It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms. All items are scoring from 0 to 6: 0: nothing 2 :light 4: important 6: extreme

  Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)

• PDS: Psychotic Depression Scale

  It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms. The overall PDS score is correlated to the overall MADRS scores. All items are scoring from 0 to 6: 0: nothing 2 :light 4: important 6: extreme

  one month after the discharge

• PDS: Psychotic Depression Scale

  It is composed of 32 items. Among the PDS items, those related to the "mood" factors depressive" (8 items) and "vegetative signs" (3 items) allow an evaluation of the depression regardless of negative symptoms or extrapyramidal symptoms. The overall PDS score is correlated to the overall MADRS scores. All items are scoring from 0 to 6: 0: nothing 2 :light 4: important 6: extreme

  Three month after the discharge

• YMRS: Young Mania Rating Scale

  The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania. This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. There are well described anchor points for each grade of severity.

  AT the beginning of the study, before any procedure (T1)

• YMRS: Young Mania Rating Scale

  The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania. This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. There are well described anchor points for each grade of severity.

  Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)

• YMRS: Young Mania Rating Scale

  The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania. This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. There are well described anchor points for each grade of severity.

  one month after the discharge

• YMRS: Young Mania Rating Scale

  The YMRS is a scale of 11 questions to assess the severity of symptoms maniacs. It is considered the gold standard of scales evaluating mania. This instrument is widely used both in the clinic and in research. It is appropriate both to assess the initial severity of manic symptoms, and the response to treatment in patients with bipolar disorder type I and II. Each item of YMRS given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. There are well described anchor points for each grade of severity.

  Three month after the discharge

• CDS: Self-Consciousness Revised Scale

  This scale represents a cross-cultural validation in of the Self-Consciousness Revised Scale by Scheier et al. This scale measures three aspects of the self-awareness, that is, private, public self-awareness and social anxiety. It includes 22 statements. The scale is rating 0-3 point: 0: not at all like me 1. a little bit like me 2. quite similar to me 3. Very much like me . The time to complete will be 10 minutes.

  Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)

• CTQ: Childhood Trauma Questionnaire

  The Child Trauma Questionnaire is a questionnaire developed by Bernstein et al. (1994) which includes 70 items with a scale of type Likert in five answer choices (from 1 = "never true" to 5 = "very often true"). It was developed from a detailed review of the literature on abuse and also from experience a structured interview, the Childhood Trauma Interview, developed by the same authors. The ten minutes will be required.

  Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)

• BFI: Big Five Inventory

  The Personality Dimension Scale, BIG FIVE, FFS: John et al. developed the Big Five Inventory (BFI). This consists of 44 items in its American version, consisting of short phrases based on the adjectives of traits known to be the prototype markers of the "Big Five" John et al. no longer denotes the factors but assigns them a letter accompanied by a set of explanatory and synthetic terms of the definition: E (Extraversion, Energy, Enthusiasm); A (Agreeability, Altruism, Affection); C (Consciousness, Control, Constraint); N (Negative Emotions, Neuroticism, Nervousness); O (Openness, Originality, Openness). The Time of passing is 10 minutes. 1. disagree strongly 2. disagree a little 3. Neither agree or nor disagree 4. agree a little 5. agree strongly

  Approximatively 2 or 3 weeks after T1 ,On the day of the discharge (T2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de Ville-Evrard, France: lead

Study Sites (1)

unité de recherche clinique de l'E.P.S de Ville Evrard

Neuilly-sur-Marne, 93332, France

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

RUSHEENTHIRA THAVASEELAN, MSc

CONTACT

0143083232; r.thavaseelan@epsve.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS, psychiatrist and investigator

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 15, 2024
• Study Start: September 20, 2016
• Primary Completion: September 6, 2025
• Study Completion (Estimated): September 6, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

FR (1)