AzTrials
AzTrials

Psychotic EpisodePEPsy-CMNCT05116514

Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.

A study testing Case management in people with Psychotic Episode, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Read more about this study

Who is it for?
Ages 16 to 30 years
Conditions the study is for
Psychotic Episode
What is being tested?
Case management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
6 sitesFrance
Study dates
27 Sep 2021to Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 16 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • The patient or their close relative must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is available for a 3-year follow-up.
  • Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by:
  • Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ;
  • Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry);
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  • A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features.
  • Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.
  • At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.

Who cannot join

  • The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
  • The subject, or one of the parents for minor patients, refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patients has an IQ less than or equal to 55
  • The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition
  • The patient is pregnant or breastfeeding

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aurélie Schandrin contact

04.66.68.34.26

aurelie.schandrin@chu-nimes.fr

6 sites in 1 country

France6 sites, 6 recruiting

  • CH Saint Marie Clermont-Ferrand

    Clermont-Ferrand

    Sébastien ALMON, sebastien.almon@hotmail.fr

    Not yet recruiting

  • CHU de Montpellier

    Montpellier

    Delphine CAPDEVIELLE, 04.67.33.97.02, d-capdevielle@chu-montpellier.fr

    Delphine CAPDEVIELLE

    Recruiting

  • CHU Nice

    Nice

    Bruno GIORDANA, 04.92.03.76.09, giordana.b@chu-nice.fr

    Not yet recruiting

  • CHU de Nîmes

    Nîmes

    Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr

    Aurélie SCHANDRIN

    Recruiting

  • Centre Hospitalier Léon-Jean Grégory

    Thuir

    Aurore LARUE, 04.68.84.66.20, aurore.larue@ch-thuir.fr

    Recruiting

  • CHU de TOULOUSE

    Toulouse, Choisir Une Région, 31

    ETIENNE VERY, 05.61.77.22.33, very-e@chu-toulouse.fr

    Not yet recruiting

Other trials in France

About this study

Official title: Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode. Randomized, Open-label, Multicenter Controlled Study With Blinded Evaluation.

The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration

Being tested
Case management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Case managementOther

    Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months

Study groups in NCT05116514
Study groupRoleWhat they receive
Case manager groupExperimentalNot described
Receives: Other: Case management
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients with recurrence of psychotic episode at least once between groups

    Recurrence of the psychotic episode will be defined as psychiatric hospitalization with a diagnosis of psychotic disorder and/or the presence of positive psychotic symptoms according to the Positive and Negative Symptom Scale (PANSS) ≥ 4 for item P1 (delusions) and/or P2 (conceptual disorganization) and/or P3 (hallucination)) over a period of at least one week.

    Measured: 3 years

Secondary outcomes (194)

  1. Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

    number

    Measured: 1 year

  2. Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

    number

    Measured: 2 years

  3. Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

    number

    Measured: 3 years

  4. Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

    number

    Measured: 1 year

  5. Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

    number

    Measured: 2 years

  6. Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

    number

    Measured: 3 years

  7. Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient

    days/weeks/months

    Measured: 1 year

  8. Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient

    days/weeks/months

    Measured: 2 years

  9. Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient

    days/weeks/months

    Measured: 3 years

  10. Percentage per patient of medical and caregiving appointments honored between groups

    %

    Measured: Inclusion

  11. Percentage per patient of medical and caregiving appointments honored between groups

    %

    Measured: 6 months

  12. Percentage per patient of medical and caregiving appointments honored between groups

    %

    Measured: 1 year

  13. Percentage per patient of medical and caregiving appointments honored between groups

    %

    Measured: 18 months

  14. Percentage per patient of medical and caregiving appointments honored between groups

    %

    Measured: 2 years

  15. Percentage per patient of medical and caregiving appointments honored between groups

    %

    Measured: 2.5 years

  16. Percentage per patient of medical and caregiving appointments honored between groups

    %

    Measured: 3 years

  17. Type of hospital admission (voluntary versus involuntary) between groups

    % voluntary versus involuntary

    Measured: Inclusion

  18. Type of hospital admission (voluntary versus involuntary) between groups

    % voluntary versus involuntary

    Measured: 6 months

  19. Type of hospital admission (voluntary versus involuntary) between groups

    % voluntary versus involuntary

    Measured: 1 year

  20. Type of hospital admission (voluntary versus involuntary) between groups

    % voluntary versus involuntary

    Measured: 18 months

  21. Type of hospital admission (voluntary versus involuntary) between groups

    % voluntary versus involuntary

    Measured: 2 years

  22. Type of hospital admission (voluntary versus involuntary) between groups

    % voluntary versus involuntary

    Measured: 2.5 years

  23. Type of hospital admission (voluntary versus involuntary) between groups

    % voluntary versus involuntary

    Measured: 3 years

  24. Unscheduled discharge from care between groups

    Defined by a break in follow-up organized by the referring care team for more than 30 days

    Measured: Inclusion

  25. Unscheduled discharge from care between groups

    Defined by a break in follow-up organized by the referring care team for more than 30 days

    Measured: 6 months

  26. Unscheduled discharge from care between groups

    Defined by a break in follow-up organized by the referring care team for more than 30 days

    Measured: 1 year

  27. Unscheduled discharge from care between groups

    Defined by a break in follow-up organized by the referring care team for more than 30 days

    Measured: 18 months

  28. Unscheduled discharge from care between groups

    Defined by a break in follow-up organized by the referring care team for more than 30 days

    Measured: 2 years

  29. Unscheduled discharge from care between groups

    Defined by a break in follow-up organized by the referring care team for more than 30 days

    Measured: 2.5 years

  30. Unscheduled discharge from care between groups

    Defined by a break in follow-up organized by the referring care team for more than 30 days

    Measured: 3 years

  31. Treatment compliance between groups

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

    Measured: Inclusion

  32. Treatment compliance between groups

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

    Measured: 6 months

  33. Treatment compliance between groups

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

    Measured: 1 year

  34. Treatment compliance between groups

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

    Measured: 18 months

  35. Treatment compliance between groups

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

    Measured: 2 years

  36. Treatment compliance between groups

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

    Measured: 2.5 years

  37. Treatment compliance between groups

    item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment)

    Measured: 3 years

  38. Adherence to treatment

    Medication Adherence Rating Scale (MARS, self-administered questionnaire)

    Measured: 1 year

  39. Adherence to treatment

    Medication Adherence Rating Scale (MARS, self-administered questionnaire)

    Measured: 2 years

  40. Adherence to treatment

    Medication Adherence Rating Scale (MARS, self-administered questionnaire)

    Measured: 3 years

  41. Therapeutic alliance

    Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)

    Measured: 1 year

  42. Therapeutic alliance

    Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)

    Measured: 2 years

  43. Therapeutic alliance

    Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire)

    Measured: 3 years

  44. Patient awareness of disorders and of the need for treatment

    Birchwood Insight Scale (BIS, self-administered questionnaire)

    Measured: 1 year

  45. Patient awareness of disorders and of the need for treatment

    Birchwood Insight Scale (BIS, self-administered questionnaire)

    Measured: 2 years

  46. Patient awareness of disorders and of the need for treatment

    Birchwood Insight Scale (BIS, self-administered questionnaire)

    Measured: 3 years

  47. Assessment of addictive comorbidities

    semi-structured clinical interview for DSM (SCID)

    Measured: Inclusion

  48. Assessment of addictive comorbidities

    semi-structured clinical interview for DSM (SCID)

    Measured: 3 years

  49. Assessment of tobacco, alcohol and drug use

    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

    Measured: Every 6 months from inclusion

  50. Evaluation of the clinical impact of the intervention between groups

    Clinical Global Impression questionnaire (CGI)

    Measured: Every 6 months from inclusion

  51. Psychotic and general symptoms

    Positive and Negative Symptom Scale (PANSS)

    Measured: Every 6 months from inclusion

  52. Depressive symptoms

    Calgary Depression Scale for Schizophrenia (CDSS)

    Measured: Every 6 months from inclusion

  53. Self- and hetero-aggressive behaviors

    according to Health of the Nation Outcome Scales (HoNOS) items 1 and 2

    Measured: Every 6 months from inclusion

  54. Reported adverse events

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

    Measured: Inclusion

  55. Reported adverse events

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

    Measured: 6 months

  56. Reported adverse events

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

    Measured: 1 year

  57. Reported adverse events

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

    Measured: 18 months

  58. Reported adverse events

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

    Measured: 2 years

  59. Reported adverse events

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

    Measured: 2.5 years

  60. Reported adverse events

    death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS

    Measured: 3 years

  61. Current suicidal ideations

    Calgary Depression Scale for Schizophrenia (CDSS)

    Measured: Inclusion

  62. Current suicidal ideations

    Calgary Depression Scale for Schizophrenia (CDSS)

    Measured: 6 months

  63. Current suicidal ideations

    Calgary Depression Scale for Schizophrenia (CDSS)

    Measured: 1 year

  64. Current suicidal ideations

    Calgary Depression Scale for Schizophrenia (CDSS)

    Measured: 18 months

  65. Current suicidal ideations

    Calgary Depression Scale for Schizophrenia (CDSS)

    Measured: 2 years

  66. Current suicidal ideations

    Calgary Depression Scale for Schizophrenia (CDSS)

    Measured: 2.5 years

  67. Current suicidal ideations

    Calgary Depression Scale for Schizophrenia (CDSS)

    Measured: 3 years

  68. Assess the impact of the intervention on socio-professional functioning and quality of life

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

    Measured: Inclusion

  69. Assess the impact of the intervention on socio-professional functioning and quality of life

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

    Measured: 6 months

  70. Assess the impact of the intervention on socio-professional functioning and quality of life

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

    Measured: 1 year

  71. Assess the impact of the intervention on socio-professional functioning and quality of life

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

    Measured: 18 months

  72. Assess the impact of the intervention on socio-professional functioning and quality of life

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

    Measured: 2 years

  73. Assess the impact of the intervention on socio-professional functioning and quality of life

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

    Measured: 2.5 years

  74. Assess the impact of the intervention on socio-professional functioning and quality of life

    Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation

    Measured: 3 years

  75. Social and occupational functioning

    Social and Occupational Functioning Assessment Scale (SOFAS)

    Measured: Inclusion

  76. Social and occupational functioning

    Social and Occupational Functioning Assessment Scale (SOFAS)

    Measured: 6 months

  77. Social and occupational functioning

    Social and Occupational Functioning Assessment Scale (SOFAS)

    Measured: 1 year

  78. Social and occupational functioning

    Social and Occupational Functioning Assessment Scale (SOFAS)

    Measured: 18 months

  79. Social and occupational functioning

    Social and Occupational Functioning Assessment Scale (SOFAS)

    Measured: 2 years

  80. Social and occupational functioning

    Social and Occupational Functioning Assessment Scale (SOFAS)

    Measured: 2.5 years

  81. Social and occupational functioning

    Social and Occupational Functioning Assessment Scale (SOFAS)

    Measured: 3 years

  82. Social functioning

    Health of the Nation Outcome Scales

    Measured: Inclusion

  83. Social functioning

    Health of the Nation Outcome Scales

    Measured: 6 months

  84. Social functioning

    Health of the Nation Outcome Scales

    Measured: 1 year

  85. Social functioning

    Health of the Nation Outcome Scales

    Measured: 18 months

  86. Social functioning

    Health of the Nation Outcome Scales

    Measured: 2 years

  87. Social functioning

    Health of the Nation Outcome Scales

    Measured: 2.5 years

  88. Social functioning

    Health of the Nation Outcome Scales

    Measured: 3 years

  89. Psychosocial functioning

    Quality of Life Scale (QLS) - semi-structured interview

    Measured: Inclusion

  90. Psychosocial functioning

    Quality of Life Scale (QLS) - semi-structured interview

    Measured: 6 months

  91. Psychosocial functioning

    Quality of Life Scale (QLS) - semi-structured interview

    Measured: 1 year

  92. Psychosocial functioning

    Quality of Life Scale (QLS) - semi-structured interview

    Measured: 18 months

  93. Psychosocial functioning

    Quality of Life Scale (QLS) - semi-structured interview

    Measured: 2 years

  94. Psychosocial functioning

    Quality of Life Scale (QLS) - semi-structured interview

    Measured: 2.5 years

  95. Psychosocial functioning

    Quality of Life Scale (QLS) - semi-structured interview

    Measured: 3 years

  96. Functioning

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

    Measured: Inclusion

  97. Functioning

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

    Measured: 6 months

  98. Functioning

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

    Measured: 1 year

  99. Functioning

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

    Measured: 18 months

  100. Functioning

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

    Measured: 2 years

  101. Functioning

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

    Measured: 2.5 years

  102. Functioning

    Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire

    Measured: 3 years

  103. Quality of life of users (patient and family)

    World Health Organization Quality of Life brief (WHOQOL-brief)

    Measured: 1 year

  104. Quality of life of users (patient and family)

    World Health Organization Quality of Life brief (WHOQOL-brief)

    Measured: 2 years

  105. Quality of life of users (patient and family)

    World Health Organization Quality of Life brief (WHOQOL-brief)

    Measured: 3 years

  106. Health-related quality of life

    EuroQol-5D 3 level version (EQ-5D-35L)

    Measured: 1 year

  107. Health-related quality of life

    EuroQol-5D 3 level version (EQ-5D-35L)

    Measured: 2 years

  108. Health-related quality of life

    EuroQol-5D 3 level version (EQ-5D-35L)

    Measured: 3 years

  109. Quality of life of relatives

    caregiver schizophrenia quality of life questionnaire (S-CGQoL)

    Measured: 1 year

  110. Quality of life of relatives

    caregiver schizophrenia quality of life questionnaire (S-CGQoL)

    Measured: 2 years

  111. Quality of life of relatives

    caregiver schizophrenia quality of life questionnaire (S-CGQoL)

    Measured: 3 years

  112. Cost-outcome type ratio

    the ratio of the difference in costs between the two strategies divided by the difference in QALYs. This ratio measures the cost per life-year gained in full health, i.e. a cost per QALY. This indicator is obtained by weighting the time spent in each health state h by the utility of that health state measured by the EQ-5D

    Measured: 3 years

  113. Cost of care

    assessed from a community perspective (health care system, out-of-pocket expenses, caregivers)

    Measured: 3 years

  114. Budget impact analysis between strategies

    National estimates of avoided costs, care consumption and the cost of implementing the system in the two management strategies

    Measured: 3 years

  115. Psychiatric assessment

    Structured Clinical Interview for DSM

    Measured: Inclusion

  116. Psychiatric assessment

    Structured Clinical Interview for DSM

    Measured: 3 years

  117. Patient age

    Measured: Inclusion

  118. Patient sex

    Measured: Inclusion

  119. Current patient professional/training situation

    working or studying

    Measured: Over the study until 3 years

  120. Financial situation

    Measured: Over the study until 3 years

  121. Care pathways taken by patient

    specialist care sought

    Measured: Over the study until 3 years

  122. Duration of non-treated psychosis

    Interval between start of psychotic symptoms and start of sufficient antipsychotic treatment

    Measured: Inclusion

  123. Personal and family psychiatric history

    Measured: Inclusion

  124. Social and academic function

    Premorbid Adjustment Scale

    Measured: Inclusion

  125. Medical treatment received

    Measured: Until 3 years

  126. Cerebral imagery

    Normal/abnormal

    Measured: Inclusion

  127. Cerebral imagery

    Normal/abnormal

    Measured: 1 year

  128. Cerebral imagery

    Normal/abnormal

    Measured: 2 years

  129. IQ profile

    Homogenous/heterogenous

    Measured: Inclusion

  130. IQ profile

    Homogenous/heterogenous

    Measured: 1 year

  131. IQ profile

    Homogenous/heterogenous

    Measured: 2 years

  132. IQ

    value

    Measured: Inclusion

  133. IQ

    value

    Measured: 1 year

  134. IQ

    value

    Measured: 2 years

  135. BMI

    kg/m2

    Measured: Inclusion

  136. BMI

    kg/m2

    Measured: 1 year

  137. BMI

    kg/m2

    Measured: 2 years

  138. Fasting glycemia

    mmol/l

    Measured: Inclusion

  139. Fasting glycemia

    mmol/l

    Measured: 1 year

  140. Fasting glycemia

    mmol/l

    Measured: 2 years

  141. Lipid assessment

    Normal/abnormal

    Measured: Inclusion

  142. Lipid assessment

    Normal/abnormal

    Measured: 1 year

  143. Lipid assessment

    Normal/abnormal

    Measured: 2 years

  144. Whole blood count

    Normal/abnormal

    Measured: Inclusion

  145. Whole blood count

    Normal/abnormal

    Measured: 1 year

  146. Whole blood count

    Normal/abnormal

    Measured: 2 years

  147. Electrolytes

    Normal/abnormal

    Measured: Inclusion

  148. Electrolytes

    Normal/abnormal

    Measured: 1 year

  149. Electrolytes

    Normal/abnormal

    Measured: 2 years

  150. Neurological exam

    Normal/abnormal

    Measured: Inclusion

  151. Neurological exam

    Normal/abnormal

    Measured: 1 year

  152. Neurological exam

    Normal/abnormal

    Measured: 2 years

  153. Cardiovascular exam

    Normal/abnormal

    Measured: Inclusion

  154. Cardiovascular exam

    Normal/abnormal

    Measured: 1 year

  155. Cardiovascular exam

    Normal/abnormal

    Measured: 2 years

  156. Morphological exam

    Normal/abnormal

    Measured: Inclusion

  157. Morphological exam

    Normal/abnormal

    Measured: 1 year

  158. Morphological exam

    Normal/abnormal

    Measured: 2 years

  159. Hepatic exam

    Normal/abnormal

    Measured: Inclusion

  160. Hepatic exam

    Normal/abnormal

    Measured: 1 year

  161. Hepatic exam

    Normal/abnormal

    Measured: 2 years

  162. Presence of neurometabolic disease

    Yes/no

    Measured: Inclusion

  163. Presence of neurometabolic disease

    Yes/no

    Measured: 1 year

  164. Presence of neurometabolic disease

    Yes/no

    Measured: 2 years

  165. Electrocardiogram

    Normal/abnormal

    Measured: Inclusion

  166. Electrocardiogram

    Normal/abnormal

    Measured: 1 year

  167. Electrocardiogram

    Normal/abnormal

    Measured: 2 years

  168. C-reactive protein

    mg/l

    Measured: Inclusion

  169. C-reactive protein

    mg/l

    Measured: 1 year

  170. C-reactive protein

    mg/l

    Measured: 2 years

  171. thyroid-stimulating hormone

    mUI/l

    Measured: Inclusion

  172. thyroid-stimulating hormone

    mUI/l

    Measured: 1 year

  173. thyroid-stimulating hormone

    mUI/l

    Measured: 2 years

  174. Cortisol

    nmol/l

    Measured: Inclusion

  175. Cortisol

    nmol/l

    Measured: 1 year

  176. Cortisol

    nmol/l

    Measured: 2 years

  177. Adverse events

    Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other

    Measured: Inclusion

  178. Adverse events

    Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other

    Measured: 1 year

  179. Adverse events

    Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other

    Measured: 2 years

  180. Non-medical treatment received

    Psychosocial/psychotherapy interventions

    Measured: Until 3 years

  181. In the experimental group: case management according to good practice guidelines

    EPPIC Model Integrity Tool (80 items with subscores)

    Measured: End of follow-up (3 years)

  182. In the experimental group: Conformity of case management

    Index of Fidelity to Assertive Community Treatment (16 criteria of conformity for three dimensions)

    Measured: End of study (5 years)

  183. In the experimental group: conformity to TIDieR checklist in each patient

    TIDieR checklist-patient

    Measured: Month 3

  184. In the experimental group: conformity to TIDieR checklist in each patient

    TIDieR checklist-patient

    Measured: Month 6

  185. In the experimental group: conformity to TIDieR checklist in each patient

    TIDieR checklist-patient

    Measured: 1 year

  186. In the experimental group: conformity to TIDieR checklist in each patient

    TIDieR checklist-patient

    Measured: 18 Months

  187. In the experimental group: conformity to TIDieR checklist in each patient

    TIDieR checklist-patient

    Measured: 2 years

  188. In the experimental group: conformity to TIDieR checklist in each patient

    TIDieR checklist-patient

    Measured: 30 Months

  189. In the experimental group: conformity to TIDieR checklist in each patient

    TIDieR checklist-patient

    Measured: 3 years

  190. In the experimental group: conformity to TIDieR checklist in each center

    Customized TIDieR checklist-center

    Measured: Annually until end of study (5 years)

  191. Satisfaction of patients and their families

    Client Satisfaction Questionnaire (CSQ)-8

    Measured: 1 year

  192. Satisfaction of patients and their families

    Client Satisfaction Questionnaire (CSQ)-8

    Measured: 2 years

  193. Satisfaction of patients and their families

    Client Satisfaction Questionnaire (CSQ)-8

    Measured: 3 years

  194. Satisfaction of participants receiving help from a health coordinator

    7-item custom questionnaire with free answer section

    Measured: End of follow-up (3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2021
  2. Study start27 Sep 2021
  3. Primary completionSep 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05116514
Sponsor's protocol ID
PREPS/2018/AS-01
Acronym
PEPsy-CM
Status last verified
Dec 2025
First submitted
5 Oct 2021
Last updated
31 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Schandrin A, Jourdan J, Chkair S, Bouvet S, Fabbro-Peray P, Abbar M; PEPsy-CM working group. PEPsy-CM study protocol: impact of a 3-year program for early psychosis based on case-management on relapse rate, a French multicenter randomized trial. BMC Psychiatry. 2025 May 15;25(1):488. doi: 10.1186/s12888-025-06940-y.

    PubMed 40375175

Questions about this trial

What is this clinical trial studying?

A study testing Case management in people with Psychotic Episode, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.

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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aurélie Schandrin (04.66.68.34.26, aurelie.schandrin@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients with recurrence of psychotic episode at least once between groups (time frame: 3 years). 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 NCT05116514, which also lists 1 linked publication.

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 31 Dec 2025.

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