Trial document




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  DRKS00016043

Trial Description

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Title

Effects of early clozapine treatment on remission rates in acute schizophrenia (EARLY)

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Trial Acronym

EARLY

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URL of the Trial

http://www.early-studie.de

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Brief Summary in Lay Language

The main objective is to investigate the symptomatic remission rates in non-treatment-refractory patients with schizophrenia treated wether with early clozapine or with olanzapine over an 8-week period. Other objectives include differences in side effects, symptom severity, safety measures and cognitive functions.

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Brief Summary in Scientific Language

The primary objective is to investigate the symptomatic remission rates in non-treatment-refractory patients with schizophrenia randomized to either early clozapine or olanzapine over an 8-week period.
Secondary objectives include differences in side effects, symptom severity, safety measures and cognitive functions.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

not applicable

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Organizational Data

  •   DRKS00016043
  •   2018/12/17
  •   [---]*
  •   yes
  •   Approved
  •   18-674 fed, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   2018-001514-15 
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Health Condition or Problem studied

  •   DSM V: acute schizophrenia
  •   F20 -  Schizophrenia
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Interventions/Observational Groups

  •   Clozapine (75 to 600 mg/d) with an intervention period of 8 weeks
  •   Olanzapine (2.5 to 20 mg/d) with an intervention period of 8 weeks
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   Yes
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Primary Outcome

Relative frequency of patients in the clozapine group in remission (Remission in Schizophrenia Working Group [RSWG] consensus criteria) at week eight compared to the olanzapine group.

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Secondary Outcome

The following measures will be compared between study arms: early response and remission rates (Positive and Negative Symptom Scale, PANSS); Thought and Language Disorder (TALD) scale, cognition (Trail-Making Test, TMT); Clinical Global Impression (CGI); functioning (Global Assessment of Functioning, GAF); depression (Calgary Depression Scale for Schizophrenia, CDSS);, abbreviated quality of life enjoyment and satisfaction questionnaire (Q-LES-Q-18); health situation (SF-12); adverse events: Glasgow Antipsychotic Side-effects Scale for Clozapine, GASS for Clozapine; Drug Attitude Inventory (DAI); views of patients and relatives on treatment (Subjective Wellbeing under Neuroleptics, SWN); Change in Personal and Social Performance Scale (PSP); Attitude towards participation in clinical research; InterSePT scale for suicidal thinking (ISST)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/06/17
  •   220
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

1. Age 18 to 65 years
2. Signed informed consent
3. DSM-V diagnosis of schizophrenia confirmed by the Mini international Neuropsychiatric Interview
4. At least one documented prior hospitalization due to the illness in the medical history (the current hospitalization can be considered as “prior” hospitalization if its ≥ 4 weeks) at screening
5. For treatment-naïve patients (defined as no previous antipsychotic treatment or a maximum of 30 days of treatment), an antipsychotic treatment attempt of at least 30 days with an antipsychotic in a therapeutic dose according to local guidelines other than clozapine and olanzapine before the screening phase is needed. For non- treatment-naïve patients (defined as having been treated for more than 30 days with an antipsychotic), a discontinuation of a foregoing antipsychotic treatment prior to the screening phase within a maximum of six months (=180 days) is possible (corresponding to the estimated average time for an antipsychotic washout phase and the expected time to develop a relapse of the disease). For patients being treated with a long-acting antipsychotic (other than PP3M), an inclusion is possible if inclusion date corresponds to the planned date
of the next injection plus five to seven days
6. Clinical need for a medication switch because of clinical inefficacy or side-effects or clinical need for a reintroduction of an antipsychotic treatment after treatment discontinuation prior to the screening phase (see 5.)
7. Moderate symptomatology on the PANSS, defined as a score ≥ 4 for two or more symptoms from P1-P7 or a score of ≥ 6 for one symptom from P1-P7 (minimum threshold definition) at screening
8. Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening.
This includes:
• A woman who is not capable of bearing a child is defined as follows: post-menopausal (12 months natural (spontaneous) amenorrhea or 6 months spontaneous amenorrhea with serum-FSH-values (follicle-stimulating hormone) of >40 mIU/mL); 6 weeks after a bilateral ovariectomy with or without hysterectomy or sterilization by means of tubal ligation
• A woman capable of bearing child is defined as follows: a woman who is physiologically capable of becoming pregnant, including women whose occupation, lifestyle or sexual orientation exclude sexual intercourse with a male partner and women whose partners have been sterilized by vasectomy or other measures.
• Medically-approved methods of contraception can include the following: hormonal contraceptives, intrauterine device and double barrier method. Acceptable preventive measures can include total abstinence at the discretion of the investigator, in cases where compliance is ensured because of the study participant’s age, occupation, lifestyle or sexual orientation. Periodical abstinence (e.g. calendar, ovulation, symptothermal methods or abstinence until the 4th day after the ovulation) as well as coitus interruptus are not acceptable methods of contraception.
• A reliable method of contraception (CTFG guideline) must be used for the entire duration of the study.

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Exclusion Criteria

1. Patients who are not suitable for the study in the opinion of the investigator
2. Patients who are unable to give informed consent
3. Coercive treatment at the time of study inclusion
4. White blood cell count (WBC) at inclusion not meeting the requirements for clozapine use in Germany. Patients must have normal leukocyte findings (white blood cell count ≥ 3500/mm3 (≥ 3.5x109/l), and Absolute Neutrophil Count (ANC) ≥ 2000/mm3 (≥ 2.0x109/l) at the screening visit
5. The presence of one or more of the contraindications against any of the study drugs as mentioned in the SmPC
6. Treatment-naïve or treatment-resistant schizophrenia. Treatment-naïve will be defined as no previous antipsychotic treatment or a maximum of 30 days of treatment. Treatment resistance is defined as 2 antipsychotic trials (with antipsychotics from two different chemical classes) for a period of ≥ 6 weeks with CPZ equivalent doses ≥ 600 mg/day, both of which took place immediately before the screening phase
7. Diagnosis of primary substance dependency other than nicotine
8. Documented previous non-response to an 8-week drug trial with olanzapine or any documented previous treatment with clozapine
9. Intolerance to one of the study drugs
10. Pregnancy (incl. positive blood pregnancy test) / lactation (female patients)

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Addresses

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    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Projektmanagement klinische StudienKlinikum rechts der IsarMünchner Studienzentrum
    • Ms.  Beate  Schossow 
    • Ismaninger Straße 22
    • 81675  München
    • Germany
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    • Klinikum der Universität München, AöRKlinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  PD Dr.med.  Alkomiet  Hasan 
    • Nussbaumstraße 7
    • 80336  München
    • Germany
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    • Klinikum der Universität München, AöRKlinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  Dipl. Ing.  Thomas  Görlitz 
    • Nussbaumstrasse 7
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft e.V.
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    •   +49 (228) 885-1
    •   +49 (228) 885-2777
    •   [---]*
    •   http://www.dfg.de
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.