The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

The Efficacy for Execution Function and Genetic Mechanism of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

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) .

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: Cognitive Remediation Therapy; Drug: Clozapine

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).

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20000
      • Huangpu District Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cognitive Remediation Therapy; 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.	Other: Cognitive Remediation Therapy; 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.; Other Names: CCRT; Drug: Clozapine; the course of disease is more than 2 years, the condition is stable for more than one month; Other Names: CLZ
PLACEBO_COMPARATOR: Clozapine; Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.	Drug: Clozapine; the course of disease is more than 2 years, the condition is stable for more than one month; Other Names: CLZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 baseline
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 end of 12 week
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 baseline
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 end of 12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 baseline
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 end of 12 week

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Study Director: tao shen, professor, Shanghai Huangpu District Health and Wellness Committee

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2019
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: December 9, 2018
• First Posted (ACTUAL): December 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; GABA Agents; GABA Antagonists; Clozapine
• Other Study ID Numbers: HKQ201813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No