Clinical trial NCT03772951: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The score of Positive and Negative Syndrome Scale (PANSS)
timeFrame: the baseline
measure: The score of Positive and Negative Syndrome Scale (PANSS)
timeFrame: the end of 12 week
measure: The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment
timeFrame: the baseline
measure: The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment
timeFrame: the end of 12 week
Secondary outcomes:
measure: The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment
timeFrame: the baseline
measure: The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment
timeFrame: the end of 12 week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huangpu District Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Huangpu District Health and Wellness Committee
name: tao shen, professor
role: STUDY_DIRECTOR
References: