Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia (CAVES)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Cognitive Impairment With Primary Psychotic Disorder; Negative Symptoms With Primary Psychotic Disorder

Treatments: Drug: Usual Antipsychotic Treatment; Drug: Vortioxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT04895488

2021-001333-38 (EudraCT Number)

CAVES

Details and patient eligibility

About

Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.

Full description

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.

Enrollment: 37 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

1. Patients taking any antidepressant and its use cannot be discontinued at least 8 weeks prior to randomization.
2. Structural brain disease (based on previous medical records)
3. Cognitive disability by history and estimated intelligence quotient (IQ) <70 (ID DSM-5 diagnosis).
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.
5. Organic mental disorders, or mental disorders due to a general medical condition. Any neurological or neurodegenerative disorders.
6. Any current diagnosis of substance abuse or dependence.
7. Serious risk of suicide.
8. Patients with thyroid conditions.
9. Intolerance to or inefficacy of vortioxetine in the past. Patients who had failed treatment with vortioxetine were also excluded.
10. Pregnant or breastfeeding female.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Arm A: Vortioxetine+Usual antipsychotic treatment (TAU)

Experimental group

Description:

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

Treatment:

Drug: Vortioxetine

Drug: Usual Antipsychotic Treatment

Arm B: Usual antipsychotic treatment (TAU)

Active Comparator group

Description:

Second treatment phase: Usual antipsychotic treatment: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.

Treatment:

Drug: Vortioxetine

Drug: Usual Antipsychotic Treatment