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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001333-38 | EudraCT Number |
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Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.
Clinical trial to assess the efficacy of Vortioxetine, compared with treatment as usual in early schizophrenia. Propose: To investigate the effect of Vortioxetine in cognitive functioning and negative symptoms severity in early schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Vortioxetine+Usual antipsychotic treatment (TAU) | Experimental | Drug: First treatment phase: Vortioxetine 10 mg 1 tablet/d for 2 weeks added to Usual antipsychotic treatment, followed by Vortioxetine 20mg 1tablet/d for 22 weeks added to Usual antipsychotic treatment. Wash-out period 2 weeks |
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| Arm B: Usual antipsychotic treatment (TAU) | Active Comparator | Second treatment phase: Usual antipsychotic treatment: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | First treatment phase: vortioxetine will be initiated at 10 mg / day for 2 weeks, followed by 20 mg /day for 22 weeks. The dose of vortioxetine can be lowered to 5 mg or 10 mg for tolerability reasons at clinician criteria. Wash-out period 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores | To assess the effectiveness of Vortioxetine vs. TAU in the treatment of cognitive impairments in early psychosis, measured by the change From Baseline to Week 24 in BACS App scores using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores | Baseline, week 24, week 26 and week 50 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Negative Symptoms severity (Scale for Assessment of Negative Symptoms (SANS) and Negative Symptom Assessment-4 (NSA-4) total scores) | To assess the effectiveness of Vortioxetine vs. TAU in the treatment of negative symptoms in early psychosis, measured by the change in Negative Symptoms severity (SANS, NSA-4 total scores) from baseline to end of trial. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effectiveness of Vortioxetine vs. TAU measured by the change in general functioning | To assess the effectiveness of Vortioxetine vs. TAU in the treatment of cognitive impairments in early psychosis, measured by the change in general functioning (Global Assessment of Functioning (GAF) total score) | baseline, week 12, week 24, week 26, week 38 and week 50 |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara M. Rosso Fernández, PhD | Contact | +34 955 013414 | claram.rosso.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Benedicto Crespo Facorro, Professor | benedicto.crespo.sspa@juntadeandalucia.es | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del RocÃo | Recruiting | Seville | 41013 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2021 | May 27, 2022 |
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A two arm, Open-label, randomized, Cross-over Design and single-center clinical trial Phase II b /Phase III.
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None (Open Label)
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| Usual Antipsychotic Treatment | Drug | Second treatment phase. Usual antipsychotic treatment for 26 weeks: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician. |
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| Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50 |
| To assess the safety of Vortioxetine measured through the communication of any serious adverse event. | To assess the safety of Vortioxetine in patients with early psychosis measured through the communication of any serious adverse event evaluated for relationship with the Investigational Medicinal Product (IMP). | from informed consent form (ICF) signature to 52 weeks |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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