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The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772951
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

Study Description
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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) .

Condition or disease Intervention/treatment Phase
Schizophrenia Other: Cognitive Remediation Therapy Drug: Clozapine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy for Execution Function and Genetic Mechanism of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia
Actual Study Start Date : January 10, 2019
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine

Arms and Interventions
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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 Name: CCRT

Drug: Clozapine
the course of disease is more than 2 years, the condition is stable for more than one month
Other Name: 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 Name: CLZ


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772951


Locations
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China, Shanghai
Huangpu District Mental Health Center
Shanghai, Shanghai, China, 20000
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
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Study Director: tao shen, professor Shanghai Huangpu District Health and Wellness Committee
  Study Documents (Full-Text)

Documents provided by Shanghai Mental Health Center:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] January 5, 2019

More Information
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03772951    
Other Study ID Numbers: HKQ201813
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents