The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

NCT03772951 | Completed Phase 4

• 1 other identifier: HKQ201813
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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) .

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (4)

• The score of Positive and Negative Syndrome Scale (PANSS)

  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.

  the baseline

• The score of Positive and Negative Syndrome Scale (PANSS)

  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.

  the end of 12 week

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

  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 baseline

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

  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 end of 12 week

Secondary Outcomes (2)

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

  the baseline

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

  the end of 12 week

Study Arms (2)

Cognitive Remediation Therapy

ACTIVE COMPARATOR

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; Drug: Clozapine

Clozapine

PLACEBO COMPARATOR

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

Drug: Clozapine

Interventions

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.

Also known as: CCRT

Cognitive Remediation Therapy

Clozapine DRUG

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

Also known as: CLZ

Clozapine; Cognitive Remediation Therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Huangpu District Mental Health Center

Shanghai, Shanghai Municipality, 20000, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• tao shen, professor

  Shanghai Huangpu District Health and Wellness Committee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: December 12, 2018
• Study Start: January 10, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)