search
Back to results

The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cognitive Remediation Therapy
Clozapine
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-45 years old, Han nationality, male or female;
  2. Comply with the American Diagnostic Criteria for Mental Disorder (DSM-V) diagnostic criteria for "schizophrenia";
  3. The course of the disease and continued treatment with antipsychotic drugs for > 2 years, stable for at least one month;
  4. Positive NegativeSyndrome Scale (PANSS) < 70 points;
  5. intelligence quotient (IQ)>80;
  6. Cultural, social and educational backgrounds are sufficient to understand informed consent and research content.

Exclusion Criteria:

  1. Concomitant diagnosis in addition to Diagnostic and Statistical Manual of Mental Disorders-V other than schizophrenia;
  2. Central nervous system organic diseases;
  3. There are alcohol or other substances dependent or abused in the past two months, causing significant social and cognitive impairment;
  4. In the past year, there have been major life events such as widowhood;
  5. Those who have serious suicide attempts (the third item of the (Hamilton Depression Scale-17,HAMD-17) scale "suicide" ≥ 3 points);
  6. The current patient's severe unstable physical disease;
  7. pregnant women and lactating women;
  8. Those who have received modified electroconvulsive therapy (MECT) and repetitive Transcranial Magnetic Stimulation (rTMS) treatment in the past month;
  9. Those who have been ineffective for more than 3 months of systemic psychotherapy.

Sites / Locations

  • Huangpu District Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cognitive Remediation Therapy

Clozapine

Arm Description

The study group received antipsychotic drugs Clozapine combined with Computerized Cognitive Remediation Therapy for 4 times/week for 45 minutes each time. For a total of 12 weeks. Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.

Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.

Outcomes

Primary Outcome Measures

The score of Positive and Negative Syndrome Scale (PANSS)
The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome. The subscales are summed to compute a total score.
The score of Positive and Negative Syndrome Scale (PANSS)
The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome.The subscales are summed to compute a total score.
The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment
The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment
The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.

Secondary Outcome Measures

The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment
The Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment
The Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.

Full Information

First Posted
October 24, 2018
Last Updated
December 19, 2021
Sponsor
Shanghai Mental Health Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03772951
Brief Title
The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia
Official Title
The Efficacy for Execution Function and Genetic Mechanism of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study group received antipsychotic drugs combined with Computerized Cognitive Remediation Therapy (CCRT) for 4 times/week for 45 minutes each time. The control group only received antipsychotic drugs. For a total of 12 weeks. Brain Derived Neurotrophic Factor (BDNF) and Tropomyosin-related kinase B (Trk B) genes in peripheral blood were detected in both groups before and after treatment. Clinical symptoms and executive function assessment were performed in both groups before and after treatment. The relevance of genes and their effects on downstream protein expression levels led to a molecular genetic mechanism for the efficacy of Computerized Cognitive Remediation Therapy (CCRT) .
Detailed Description
Among the cognitive disorders of chronic schizophrenia, the most reported is the executive dysfunction of the prefrontal lobe. There is increasing evidence that Computerized Cognitive Remediation Therapy (CCRT) has a significant improvement in the implementation of schizophrenia, but the specific mechanism is unknown. Therefore, this study plans to select 154 patients with chronic schizophrenia who were hospitalized for a long time. They were randomly divided into two groups. The study group received antipsychotic drugs combined with Computerized Cognitive Remediation Therapy (CCRT) for 4 times/week for 45 minutes each time. The control group only received antipsychotic drugs. For a total of 12 weeks. brain-derived neurotrophic factor (BDNF) and tyrosine receptor kinase B(TRK-B) genes in peripheral blood were detected in both groups before and after treatment. Clinical symptoms and executive function assessment were performed in both groups before and after treatment. The relevance of genes and their effects on downstream protein expression levels led to a molecular genetic mechanism for the efficacy of Computerized Cognitive Remediation Therapy (CCRT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Remediation Therapy
Arm Type
Active Comparator
Arm Description
The study group received antipsychotic drugs Clozapine combined with Computerized Cognitive Remediation Therapy for 4 times/week for 45 minutes each time. For a total of 12 weeks. Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.
Arm Title
Clozapine
Arm Type
Placebo Comparator
Arm Description
Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.
Intervention Type
Other
Intervention Name(s)
Cognitive Remediation Therapy
Other Intervention Name(s)
CCRT
Intervention Description
Through computer information technology, using error-free, procedural learning, speech enhancement and a series of targeted computer programmatic cognitive correction tasks, patients can gradually improve problem solving and information processing capabilities, thereby improving their recognition function.
Intervention Type
Drug
Intervention Name(s)
Clozapine
Other Intervention Name(s)
CLZ
Intervention Description
the course of disease is more than 2 years, the condition is stable for more than one month
Primary Outcome Measure Information:
Title
The score of Positive and Negative Syndrome Scale (PANSS)
Description
The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome. The subscales are summed to compute a total score.
Time Frame
the baseline
Title
The score of Positive and Negative Syndrome Scale (PANSS)
Description
The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome.The subscales are summed to compute a total score.
Time Frame
the end of 12 week
Title
The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment
Description
The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
Time Frame
the baseline
Title
The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment
Description
The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
Time Frame
the end of 12 week
Secondary Outcome Measure Information:
Title
The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment
Description
The Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
Time Frame
the baseline
Title
The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment
Description
The Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
Time Frame
the end of 12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-45 years old, Han nationality, male or female; Comply with the American Diagnostic Criteria for Mental Disorder (DSM-V) diagnostic criteria for "schizophrenia"; The course of the disease and continued treatment with antipsychotic drugs for > 2 years, stable for at least one month; Positive NegativeSyndrome Scale (PANSS) < 70 points; intelligence quotient (IQ)>80; Cultural, social and educational backgrounds are sufficient to understand informed consent and research content. Exclusion Criteria: Concomitant diagnosis in addition to Diagnostic and Statistical Manual of Mental Disorders-V other than schizophrenia; Central nervous system organic diseases; There are alcohol or other substances dependent or abused in the past two months, causing significant social and cognitive impairment; In the past year, there have been major life events such as widowhood; Those who have serious suicide attempts (the third item of the (Hamilton Depression Scale-17,HAMD-17) scale "suicide" ≥ 3 points); The current patient's severe unstable physical disease; pregnant women and lactating women; Those who have received modified electroconvulsive therapy (MECT) and repetitive Transcranial Magnetic Stimulation (rTMS) treatment in the past month; Those who have been ineffective for more than 3 months of systemic psychotherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tao shen, professor
Organizational Affiliation
Shanghai Huangpu District Health and Wellness Committee
Official's Role
Study Director
Facility Information:
Facility Name
Huangpu District Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

We'll reach out to this number within 24 hrs