High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms of Schizophrenia

NCT03602716 | Terminated DMC

• 1 other identifier: 17411970000
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

schizophrenia; HD-tDCS; negative symptoms

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (8)

• the Temporal Experience of Pleasure Scale (TEPS)

  Change from baseline through study completion and sustained effects at 1 and 3 months.

• the Emotional Expression Scale (EES)

  Change from baseline through study completion and sustained effects at 1 and 3 months.

• the Belief About Pleasure Scales (BAPS)

  Change from baseline through study completion and sustained effects at 1 and 3 months.

• the Emotional Regulation Questionnaire (ERQ)

  Change from baseline through study completion and sustained effects at 1 and 3 months.

• the Beck Depression Inventory (BDI)

  Change from baseline through study completion and sustained effects at 1 and 3 months.

Study Arms (2)

HD-tDCS group

EXPERIMENTAL

This HD-tDCS group will be stimulated by active HD-tDCS.

Device: HD-tDCS

Sham HD-tDCS group

SHAM COMPARATOR

This sham HD-tDCS group will have a sham stimulation with HD-tDCS.

Device: Sham HD-tDCS

Interventions

HD-tDCS DEVICE

HD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day (+15 s fade-in and fade-out); sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. HD-tDCS will be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system.

HD-tDCS group

Sham HD-tDCS DEVICE

HD-tDCS is going to be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. This group will have a 20-min-sham stimulation.

Sham HD-tDCS group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with diagnostic schizophrenia by DSM-IV
• patients at an age between 18-60 years of Han nationality
• \) 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Chinese Academy of Sciences: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 27, 2018
• Study Start: October 16, 2018
• Primary Completion: September 26, 2020
• Study Completion: September 26, 2020
• Last Updated: August 24, 2021

Record last verified: 2020-12

Locations

CN (1)