NCT04528095

Brief Summary

The project intends to take treatment-resistant schizophrenia as the research object and uses sequential multiple assignment randomized trial(SMART) design to define the treatment recommendations of different drug regimen for treatment resistant schizophrenia and to determine the physical enhancement regimen for clozapine-resistant schizophrenia and to explore targeted regulation scheme for ultra-resistant schizophrenia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 12, 2020

Last Update Submit

August 22, 2020

Conditions

Treatment-resistant Schizophrenia

Keywords

SchizophreniaTreatment-resistantAntipsychoticsCombination

Outcome Measures

Primary Outcomes (1)

  • Response rate

    25% or greater change in Positive and Negative Syndrome Scale (PANSS)

    Change from baseline PANSS score at 12 weeks

Secondary Outcomes (9)

  • Adverse reactions

    baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks

  • Adverse reactions

    baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks

  • Adverse reactions

    baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks,32 weeks

  • Neurocognitive assessments and social function

    baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months

  • Neurocognitive assessments and social function

    baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months

  • +4 more secondary outcomes

Study Arms (6)

Clozapine

EXPERIMENTAL

Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml

Drug: Clozapine

Clozapine+Amisulpride

EXPERIMENTAL

Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d

Drug: Clozapine

Clozapine+Gingke biloba

EXPERIMENTAL

Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Gingke biloba 120-360mg/d

Drug: Clozapine

MECT

EXPERIMENTAL

MECT:The treatment lasted for 4 months,16 times in total

Device: MECT

MST

EXPERIMENTAL

MST:The treatment lasted for 4 months,16 times in total

Device: MECT

DBS

EXPERIMENTAL

Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)

Device: DBS

Interventions

ClozapineDRUG

Clozapine 400 \~ 600mg/d or plasma concentration \>350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d

Also known as: Clozapine+Amisulpride, Clozapine+Gingke biloba
ClozapineClozapine+AmisulprideClozapine+Gingke biloba
MECTDEVICE

MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total

Also known as: MST
MECTMST
DBSDEVICE

Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)

DBS

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • meet the DSM-5 diagnostic criteria for schizophrenia,
  • be 18-55 years of age,
  • treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years,
  • Informed consent.

You may not qualify if:

  • Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded.
  • Patients with contraindications to even one of the proposed treatment arms are excluded.
  • Patients with risks such as extreme agitation, stupor or suicide are excluded.
  • Female patients with pregnancy or breast-feeding are also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Schizophrenia, Treatment-ResistantSchizophrenia

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Dengtang Liu, MD

    Shanghai Mental Health Center

    STUDY CHAIR

Central Study Contacts

Dengtang Liu, MD

CONTACT

18017311138erliu110@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 27, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations

CN(1)