The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

Shanghai Mental Health Center

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Other: Cognitive Remediation Therapy; Drug: Clozapine

Study type: Interventional

Funder types: Other

Identifiers

NCT03772951

HKQ201813

Details and patient eligibility

About

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) .

Full 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).

Enrollment: 154 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups, including a placebo group

Cognitive Remediation Therapy

Active Comparator group

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.

Treatment:

Drug: Clozapine

Other: Cognitive Remediation Therapy

Clozapine

Placebo Comparator group

Description:

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

Treatment:

Drug: Clozapine