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Completed

NCT Number: NCT03772951

The Efficacy 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) .

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Huangpu District Mental Health Center

Shanghai, Shanghai Municipality, 20000, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Remediation Therapy

Other

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

Clozapine

Drug

the course of disease is more than 2 years, the condition is stable for more than one month

Other names: CLZ

Primary outcomes

  1. The score of Positive and Negative Syndrome Scale (PANSS)

    Time frame: the baseline

    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.

  2. The score of Positive and Negative Syndrome Scale (PANSS)

    Time frame: 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.

  3. The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment

    Time frame: the baseline

    The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.

  4. The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment

    Time frame: 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.

Secondary outcomes

  1. The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment

    Time frame: the baseline

    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.

  2. The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 12, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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