Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
Overview
- Phase
- Phase 2
- Intervention
- Vortioxetine
- Conditions
- Cognitive Impairment With Primary Psychotic Disorder
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM - SCID) diagnosis of Schizophrenia spectrum disorders.
- •Age \>18-50 years old
- •Stable antipsychotic medication doses during at least 4 weeks ( all second generation antipsychotics excluding clozapine).
- •No antidepressant treatment for at least 8 weeks prior to randomization.
- •PANSS Negative subscore \>14 with at least two of the items at a level \>/=4 (moderate)
- •PANSS Positive subscore \</=14 with not more than one of the items at a level \>/=4 (moderate)
- •Hamilton Depression Rating Scale (HAMD-17) total score \</=12
- •Simpson Angus Score of any item \<2
- •Behaviorally Anchored Rating Scale (BARS) of any item \</= 1
- •Competent and willing to sign informed consent
Exclusion Criteria
- •Patients taking any antidepressant and its use cannot be discontinued at least 8 weeks prior to randomization.
- •Structural brain disease (based on previous medical records)
- •Cognitive disability by history and estimated intelligence quotient (IQ) \<70 (ID DSM-5 diagnosis).
- •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.
- •Organic mental disorders, or mental disorders due to a general medical condition. Any neurological or neurodegenerative disorders.
- •Any current diagnosis of substance abuse or dependence.
- •Serious risk of suicide.
- •Patients with thyroid conditions.
- •Intolerance to or inefficacy of vortioxetine in the past. Patients who had failed treatment with vortioxetine were also excluded.
- •Pregnant or breastfeeding female.
Arms & Interventions
Arm A: Vortioxetine+Usual antipsychotic treatment (TAU)
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
Intervention: Vortioxetine
Arm A: Vortioxetine+Usual antipsychotic treatment (TAU)
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
Intervention: Usual Antipsychotic Treatment
Arm B: Usual antipsychotic treatment (TAU)
Second treatment phase: Usual antipsychotic treatment: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.
Intervention: Vortioxetine
Arm B: Usual antipsychotic treatment (TAU)
Second treatment phase: Usual antipsychotic treatment: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.
Intervention: Usual Antipsychotic Treatment
Outcomes
Primary Outcomes
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores
Time Frame: Baseline, week 24, week 26 and week 50
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
Secondary Outcomes
- 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)(Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50)