Clinical trial • Psychiatry

VORTIOXETINE HYDROBROMIDE for Schizophrenia | Schizophrenia spectrum disorders

Clinical trial of VORTIOXETINE HYDROBROMIDE for Schizophrenia | Schizophrenia spectrum disorders.

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Schizophrenia | Schizophrenia spectrum disorders
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
26-11-2024
First CTIS Authorization Date
02-12-2024

Trial design

Randomised, multiple tau comparator arms (routine clinical antipsychotics): olanzapine – max daily dose 20 mg; ziprasidone – max daily dose 160 mg; quetiapine – max daily dose 0.8 g; aripiprazole – max daily dose 30 mg; chlorpromazine – max daily dose 0.3 g; pimozide – max daily dose 20 mg; risperidone – max daily dose 10 mg; haloperidol – max daily dose 20 mg; thioridazine – max daily dose 0.3 g. (schedule not specified)-controlled trial across 1 site in Spain.

Randomised
Yes
Comparator
Multiple TAU comparator arms (routine clinical antipsychotics): OLANZAPINE – max daily dose 20 mg; ZIPRASIDONE – max daily dose 160 mg; QUETIAPINE – max daily dose 0.8 g; ARIPIPRAZOLE – max daily dose 30 mg; CHLORPROMAZINE – max daily dose 0.3 g; PIMOZIDE – max daily dose 20 mg; RISPERIDONE – max daily dose 10 mg; HALOPERIDOL – max daily dose 20 mg; THIORIDAZINE – max daily dose 0.3 g. (Schedule not specified)
Real World Control
Yes
Target Sample Size
37
Trial Duration For Participant
364

Eligibility

Recruits 37 Vulnerable population selected (isVulnerablePopulationSelected = true). Participants are psychiatric patients with schizophrenia spectrum disorders. Inclusion requires the participant to be "Competent and willing to sign informed consent"; an adult subject information and informed consent form (L1_SIS and ICF adults) is provided. No assent or proxy consent procedures are described..

Pregnancy Exclusion
10. Pregnant or breastfeeding female.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Participants are psychiatric patients with schizophrenia spectrum disorders. Inclusion requires the participant to be "Competent and willing to sign informed consent"; an adult subject information and informed consent form (L1_SIS and ICF adults) is provided. No assent or proxy consent procedures are described.

Inclusion criteria

  • {"criterion_text":"- 1. Outpatient\n- 2. Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM - SCID) diagnosis of Schizophrenia spectrum disorders.\n- 3. Age >18-50 years old\n- 4. Stable antipsychotic medication doses during at least 4 weeks ( all second generation antipsychotics excluding clozapine).\n- 5. No antidepressant treatment for at least 8 weeks prior to randomization.\n- 6. PANSS Negative subscore >14 with at least two of the items at a level >/=4 (moderate)\n- 7. PANSS Positive subscore </=14 with not more than one of the items at a level >/=4 (moderate)\n- 8. Hamilton Depression Rating Scale (HAMD-17) total score </=12\n- 9. Simpson Angus Score of any item <2\n- 10. Behaviorally Anchored Rating Scale (BARS) of any item </= 1\n- 11. Competent and willing to sign informed consent\n- 12. The patient, if a woman, must: agree not to try to become pregnant during the study and use adequate, highly effective contraception"}

Exclusion criteria

  • {"criterion_text":"- 1. Patients taking any antidepressant and its use cannot be discontinued at least 8 weeks prior to randomization.\n- 2. Structural brain disease (based on previous medical records)\n- 3. Cognitive disability by history and estimated intelligence quotient (IQ) <70 (ID DSM-5 diagnosis).\n- 4. Any serious chronic medical illnesses that may interfere with the patient's ability to comply with the study procedures or that will interfere with cognition.\n- 5. Organic mental disorders, or mental disorders due to a general medical condition. Any neurological or neurodegenerative disorders.\n- 6. Any current diagnosis of substance abuse or dependence.\n- 7. Serious risk of suicide.\n- 8. Patients with thyroid conditions.\n- 9. Intolerance to or inefficacy of vortioxetine in the past. Patients who had failed treatment with vortioxetine were also excluded.\n- 10. Pregnant or breastfeeding female."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary outcome measures: Cognitive functioning improvement assessed by the change in BACS App scores.","definition_or_measurement_approach":"Measured by the change from Baseline to Week 24 in Brief Assessment of Cognition in Schizophrenia (BACS App) scores using the Composite Z-score defined as the weighted sum of the individual patient Z-scores. Time Frame: Baseline, week 24, week 26 and week 50."}

Recruitment

Planned Sample Size
37
Recruitment Window Months
36
Consent Approach
Informed consent must be provided by competent adult participants (inclusion criteria: 'Competent and willing to sign informed consent'). Subject information and informed consent document provided: L1_SIS and ICF adults. No assent or proxy consent procedures are described. Spanish translations of trial documents/titles are present.

Geography

Total Number Of Sites
1
Total Number Of Participants
37

Spain

Earliest CTIS Part Ii Submission Date
20-11-2024
Latest Decision Or Authorization Date
06-03-2025
Processing Time Days
106
Number Of Sites
1
Number Of Participants
37

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Psiquiatry
Principal Investigator Name
Benedicto Crespo Facorro
Principal Investigator Email
benedicto.crespo.sspa@juntadeandalucia.es
Contact Person Name
Benedicto Crespo Facorro
Number Of Participants
37

Sponsor

Primary sponsor

Full Name
Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
VORTIOXETINE
Active Substance
VORTIOXETINE HYDROBROMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2
Maximum Dose
20 mg
Investigational Product Name
OLANZAPINE
Active Substance
FLUOXETINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2
Maximum Dose
20 mg
Investigational Product Name
ZIPRASIDONE
Active Substance
ZIPRASIDONE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2
Maximum Dose
160 mg
Investigational Product Name
QUETIAPINE
Active Substance
PREGABALIN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2
Maximum Dose
0.8 g
Investigational Product Name
ARIPIPRAZOLE
Active Substance
ARIPIPRAZOLE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2
Maximum Dose
30 mg
Investigational Product Name
CHLORPROMAZINE
Active Substance
CHLORPROMAZINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2
Maximum Dose
0.3 g
Investigational Product Name
PIMOZIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2
Maximum Dose
20 mg
Investigational Product Name
RISPERIDONE
Active Substance
RISPERIDONE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2
Maximum Dose
10 mg
Investigational Product Name
HALOPERIDOL
Active Substance
HALOPERIDOL DECANOATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2
Maximum Dose
20 mg
Investigational Product Name
THIORIDAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 2
Maximum Dose
0.3 g
Combination Treatment
Yes

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