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NCT Number: NCT06314204

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

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.

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Key information

Conditions

Psychotic; Disorder, Cannabis Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Neuilly-sur-Marne, 93332, France

Location status: Recruiting

Location contact

Rusheenthira THAVASEELAN, Msc

CONTACT

[email protected]

0143093232

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PANSS: Positive and Negative Syndrom Scale

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

    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.

  2. PANSS: Positive and Negative Syndrom Scale

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

    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. PANSS: Positive and Negative Syndrom Scale

    Time frame: 1 month after the discharge (T3)

    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.

  4. PANSS: Positive and Negative Syndrom Scale

    Time frame: 3 month after the discharge (T4)

    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.

  5. MCQ-SF :Marijuana Craving Questionnaire- Short Form

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

    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.

  6. MCQ-SF :Marijuana Craving Questionnaire- Short Form)

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

    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.

  7. MCQ-SF :Marijuana Craving Questionnaire- Short Form)

    Time frame: one month after the discharge

    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.

  8. MCQ-SF :Marijuana Craving Questionnaire- Short Form)

    Time frame: three month after the discharge

    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.

  9. CGI: Clinical Global Impression

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

    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.

    • Normal, not at all ill
    • Borderline mentally ill
    • Mildly ill
    • Moderately ill
    • Markedly ill
    • Severely ill
    • 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.

    • Very much improved
    • Much improved
    • Minimally improved
    • No change
    • Minimally worse
    • Much worse
    • Very much worse

  10. CGI: Clinical Global Impression

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

    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.

    • Normal, not at all ill
    • Borderline mentally ill
    • Mildly ill
    • Moderately ill
    • Markedly ill
    • Severely ill
    • 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.

    • Very much improved
    • Much improved
    • Minimally improved
    • No change
    • Minimally worse
    • Much worse
    • Very much worse

  11. CGI: Clinical Global Impression

    Time frame: one month after the discharge

    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.

    • Normal, not at all ill
    • Borderline mentally ill
    • Mildly ill
    • Moderately ill
    • Markedly ill
    • Severely ill
    • 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.

    • Very much improved
    • Much improved
    • Minimally improved
    • No change
    • Minimally worse
    • Much worse
    • Very much worse

  12. CGI: Clinical Global Impression

    Time frame: three month after the discharge

    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.

    • Normal, not at all ill
    • Borderline mentally ill
    • Mildly ill
    • Moderately ill
    • Markedly ill
    • Severely ill
    • 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.

    • Very much improved
    • Much improved
    • Minimally improved
    • No change
    • Minimally worse
    • Much worse
    • Very much worse

  13. MADRS: Montgomery Åsberg Depression Rating Scale

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

    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.

  14. MADRS: Montgomery Åsberg Depression Rating Scale

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

    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.

  15. MADRS: Montgomery Åsberg Depression Rating Scale

    Time frame: one month after the discharge

    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.

  16. MADRS: Montgomery Åsberg Depression Rating Scale

    Time frame: Three month after the discharge

    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.

  17. PDS: Psychotic Depression Scale

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

    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

  18. PDS: Psychotic Depression Scale

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

    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

  19. PDS: Psychotic Depression Scale

    Time frame: one month after the discharge

    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

  20. PDS: Psychotic Depression Scale

    Time frame: Three month after the discharge

    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

  21. YMRS: Young Mania Rating Scale

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

    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.

  22. YMRS: Young Mania Rating Scale

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

    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.

  23. YMRS: Young Mania Rating Scale

    Time frame: one month after the discharge

    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.

  24. YMRS: Young Mania Rating Scale

    Time frame: Three month after the discharge

    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.

  25. CDS: Self-Consciousness Revised Scale

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

    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

    • a little bit like me
    • quite similar to me
    • Very much like me . The time to complete will be 10 minutes.

  26. CTQ: Childhood Trauma Questionnaire

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

    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.

  27. BFI: Big Five Inventory

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

    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.

    • disagree strongly
    • disagree a little
    • Neither agree or nor disagree
    • agree a little
    • agree strongly

Study contacts

Contact information is provided by the study sponsor or research team.

RUSHEENTHIRA THAVASEELAN, MSc

CONTACT

[email protected]

0143083232

Sponsors and collaborators

Lead sponsor

Centre hospitalier de Ville-Evrard, France

Other

Registry information

Official study 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

Acronym: canhope

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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