Schizophrenia Clinical Trial
Official title:
A Research on High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms in Patients With Schizophrenia
Verified date | December 2020 |
Source | Shanghai Mental Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, investigators designed a double-blind randomized trial to prove a more reliable evidence to show how the treatment by using high-definition transcranial direct current stimulation (HD-tDCS) can relieve negative symptoms in patients with predominant negative symptoms of schizophrenia, especially on improving participants' anhedonia condition and social cognition, through stimulating the left dorsolateral prefrontal cortex (DLPFC). Participants will be divided into active and sham HD-tDCS groups equally.
Status | Terminated |
Enrollment | 12 |
Est. completion date | September 26, 2020 |
Est. primary completion date | September 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - patients with diagnostic schizophrenia by DSM-IV - patients at an age between 18-60 years of Han nationality - 1) baseline score equal or higher than 4 in at least two items in negative symptoms at PANSS; 2) or baseline score equal or higher than 3 points in at least 1/3 items (including apathy) for negative symptoms; and 3)No more than 2 items have a score higher than 3 points for positive symptoms at PANSS. - willing to participate in the experiment and take treatment Exclusion Criteria: - other psychiatric diagnoses - criteria for bipolar disorder; dementia; other psychotic disturbs; substance-related disorders - schizophrenia caused by organic diseases - other mental disorders caused by drugs and alcohol - IQ<70 - presence of serious suicidal behaviour - claustrophobic or pregnancy - metal implantation in vivo - specific tDCS limitations (such as anatomic problems and high sensitivity on current) |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Mental Health Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center | Chinese Academy of Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Positive and Negative Syndrome Scale (PANSS) | a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale. | Change from baseline through study completion and sustained effects at 1 and 3 months. | |
Primary | The Scale for the Assessment of Negative Symptoms (SANS) | a 24-items, 5-point rating scale; the 5 rating points represent increasing levels of psychopathology: 0= absent, 1= mild, 2= moderate, 3= severe, 4= extreme; of the 24 items, the first 6 items for Affective Flattening, 5 items for Alogia, 5 items for Avolition, 5 items for Anhedonia, and the remaining 3 items for Attention. | Change from baseline through study completion and sustained effects at 1 and 3 months. | |
Primary | The Clinical Assessment Interview for Negative Symptoms (CAINS) | including CAINS and CAINS self-reported checklist | Change from baseline through study completion and sustained effects at 1 and 3 months. | |
Secondary | the Temporal Experience of Pleasure Scale (TEPS) | a self-reported questionnaire | Change from baseline through study completion and sustained effects at 1 and 3 months. | |
Secondary | the Emotional Expression Scale (EES) | a self-reported questionnaire | Change from baseline through study completion and sustained effects at 1 and 3 months. | |
Secondary | the Belief About Pleasure Scales (BAPS) | a self-reported questionnaire | Change from baseline through study completion and sustained effects at 1 and 3 months. | |
Secondary | the Emotional Regulation Questionnaire (ERQ) | a self-reported questionnaire | Change from baseline through study completion and sustained effects at 1 and 3 months. | |
Secondary | the Beck Depression Inventory (BDI) | a self-reported questionnaire | Change from baseline through study completion and sustained effects at 1 and 3 months. | |
Secondary | the Effort Expenditure for Rewards Task (EEfRT) | a computer test | Change from baseline through study completion and sustained effects at 1 and 3 months. | |
Secondary | the Belief Updating Task | a computer test | Change from baseline through study completion and sustained effects at 1 and 3 months. | |
Secondary | the Anticipatory and Consummatory Pleasure (ACP) task performances | a computer test | Change from baseline through study completion and sustained effects at 1 and 3 months. |
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