Use of high definition transcranial direct current stimulation in negative symptoms of Schizophrenia and changes in proton magnetic resonance spectroscopic findings

Phase 3

Completed

Conditions: Undifferentiated schizophrenia,

Registration Number: CTRI/2019/05/018947

Lead Sponsor: Central institute of psychiatry

Brief Summary: Negative symptoms are highly relevant in the long course of schizophrenia. Antipsychotic drugs have been only mildly effective in improving negative symptoms. Negative symptoms are consistently related to specific neuroanatomical correlates, especially the prefrontal cortex. Promising results have been obtained in the study of effect of tDCS on negative symptoms. The study aims at assessing the effect of High Definition trancranial Direct Current Stimulation in negative symptoms of schizophrenia as measured by proton magnetic spectroscopic findings of left dorsolateral prefrontal cortex.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Diagnosis of Schizophrenia using Diagnostic Criteria for Research (DCR) of International Classification of Disease-10th edition (ICD-10, World Health Organization,1992) 2.Age between 18- 60 years of either sex 3.The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) negative symptoms score of more than 15 4.Scale for Assessment of Negative Symptoms (SANS) score more than 20 5.Calgary Depression Scale for Schizophrenia (CDSS) score less than 7 6.Right handed 7.Patients giving written informed consent.

Exclusion Criteria

1.Presence of co-morbid neurological or other psychiatric disorder(s).
2.Patient with co morbid substance dependence, except nicotine and caffeine.
3.Having any metallic implants/parts in body 4.Subjects who have received Electroconvulsive therapy in past 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome of the study is change in negative symptoms score as assessed at the end of 2 weeks of HDtDCS treatment with the specially designed score sheet.	PANSS, SANS, CGI, CDSS WILL BE APPLIED AT THE END OF 2 WEEKS & 6WEEKS

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are changes in the levels of GABA, Glutamate, Glutamine, N-Acetyl Aspartate & N-Acetyl Aspartyl Glutamate in Dorsolateral Prefrontal Cortex using Proton MR Spectroscopic imaging and overall severity scores on CGI.	Proton Magnetic Resonance Spectroscopy will be done before giving HD tDCS and after 2 sessions of HD tDCS and at the end of 2 weeks.

Trial Locations

Locations (1): Central Institute of Psychiatry
🇮🇳
Ranchi, JHARKHAND, India
Central Institute of Psychiatry
🇮🇳Ranchi, JHARKHAND, India
Dharani R
Principal investigator
8667413791
dharuridu@gmail.com