The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Other: Cognitive Remediation Therapy; Drug: Clozapine

• Registration Number: NCT03772951
• Lead Sponsor: Shanghai Mental Health Center

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).

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-12-09
• Study First Posted: 2018-12-12
• Study Start: 2019-01-10
• Status Verified: 2021-03
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Last Update Submitted: 2021-12-19
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Remediation Therapy	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.
Cognitive Remediation Therapy	Clozapine	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	Clozapine	Clozapine, dosage, dosage form, and frequency :300\~600 mg/d; po; duration: 12 week.

Primary Outcome Measures

Name	Time	Method
The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment	the end of 12 week	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 score of Positive and Negative Syndrome Scale (PANSS)	the end of 12 week	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.

Secondary Outcome Measures

Name	Time	Method
The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment	the end of 12 week	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.

Trial Locations

Locations (1)

Huangpu District Mental Health Center; 🇨🇳 Shanghai, Shanghai, China