Treatment of cognitive deficit in schizophrenia patients with transcranial direct current stimulation augmented with cognitive training

Not Applicable

• Conditions: Mental and Behavioural Disorders; Schizophrenia; Amelioration of cognitive deficit in schizophrenia

• Registration Number: ISRCTN13247154
• Lead Sponsor: ational Institute of Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-18
• Last Update Posted: 13 November 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male and female inpatients or outpatients aged 18-50 years
2. Meet ICD-10 criteria for schizophrenia (F20)
3. The mental ability to understand and sign the Informed Consent Form
4. Being on a stable and adequate dose of antipsychotics (monotherapy or combination) for at least two weeks before enrollment and if clinically appropriate to continue on an unchanged dose of antipsychotics during the trial
5. The score for mildly to moderately ill patients in the Positive and Negative Syndrome Scale (PANSS </= 75) at the initial visit

Exclusion Criteria

1. Psychiatric comorbidity on axis I and II according to DSM V in the 6 months before enrollment to the study
2. Contraindications of tDCS (skin disease, superficial injury and fracture or infraction of skull in the stimulation area, epilepsy, metallic plates in the head)
3. Inadequate treatment of psychosis according to recommended guidelines (duration, dose)
4. Pregnancy or breastfeeding
5. Patients with severe and/or unstable somatic disorders (cardiovascular, disease, neoplasms, endocrinology disorders etc)
6. Patients treated with electroconvulsive therapy less than 3 months before enrollment or suffering from neurological disorder (e.g. epilepsy, head trauma with loss of consciousness)
7. Substantial suicidal risk as judged by the treating psychiatrist
8. History of substance-induced disorders in the last year except for nicotine dependency
9. Sensory and motor impairment precluding the participation in CT

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive functions assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at baseline, 1-week endpoint and 3-week endpoint

Secondary Outcome Measures

Name	Time	Method
Symptom severity measured by the Positive and Negative Syndrome Scale (PANSS) at baseline, 1-week endpoint and 3-week endpoint