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CompletedNCT03772951Updated Jan 11, 2022

The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia

A Phase 4 interventional study of Cognitive Remediation Therapy and Clozapine in Schizophrenia, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Shanghai Mental Health Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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) .

Read the 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).

02

Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's enrollment of 154 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 271 studies on the registry; 91 are open to participants now.

Browse Shanghai Mental Health Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
154 participants (actual)

Study arms

  • 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 · Drug: Clozapine

  • Placebo comparator
    Clozapine

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

    Drug: Clozapine

Interventions

  • OtherCognitive 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.

    Also known as: CCRT

  • DrugClozapine

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

    Also known as: CLZ

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: the baseline

  2. 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.

    Time frame: the end of 12 week

  3. 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.

    Time frame: the baseline

  4. 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.

    Time frame: the end of 12 week

Secondary outcomes

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

    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.

    Time frame: the baseline

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

    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.

    Time frame: the end of 12 week

07

Study locations

1 site
  • Huangpu District Mental Health Center
    Shanghai, Shanghai Municipality 20000, China
08

References and documents

Study documents

  • Protocol, analysis plan and consent form · Jan 5, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in Mar 2021, 26 months.

Of 74 non-industry phase 4 interventional studies under Schizophrenia, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 66. This study's 26 months is below that.

Counting every sponsor, half of 90 studies reached it within 39 months; a quarter within 20 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2018
First posted
Dec 12, 2018
StartActual
Jan 10, 2019
Primary completionActual
Mar 31, 2021
CompletionActual
Mar 31, 2021
Last update
Jan 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03772951
Lead sponsor
Shanghai Mental Health Center
Responsible party
Sponsor
First posted
Dec 12, 2018
Start date
Jan 10, 2019
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Last update
Jan 11, 2022

Study contacts

tao shen, professor
study director · Shanghai Huangpu District Health and Wellness Committee

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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