NCT02040883

Brief Summary

Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve Cognitive function in 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
100

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_4 schizophrenia

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

January 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

January 14, 2014

Last Update Submit

January 17, 2014

Conditions

Schizophrenia

Keywords

SchizophreniaTandospironeCognitive Therapy

Outcome Measures

Primary Outcomes (1)

  • Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score

    From baseline to 12 weeks of treatment

Secondary Outcomes (7)

  • MATRICS Consensus Cognitive Battery(MCCB) factor score

    From baseline to 12 weeks of treatment

  • Positive and Negative Syndrome Scale(PANSS) total score

    From baseline to 12 weeks of treatment

  • Positive and Negative Syndrome Scale(PANSS) factor score

    From baseline to 12 weeks of treatment

  • Personal and Social Performance Scale(PSP) total score

    From baseline to 12 weeks of treatment

  • Clinical Global Impression(CGI) factor score

    From baseline to 12 weeks of treatment

  • +2 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Treated with a stable dose of an AAPD for at least three months before enrollment; Atypical antipsychotic drugs(AAPDs): Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole

Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole

Study Group

EXPERIMENTAL

Atypical antipsychotic drugs(AAPDs) and Tandospirone ; Atypical antipsychotic drugs(AAPDs) ,treated with a stable dose of an AAPD for at least three months before enrollment; AAPD: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole; Tandospirone, 30mg per day;

Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/AripiprazoleDrug: Tandospirone

Interventions

Risperidone/Olanzapine/Quetiapine/Ziprasidone/AripiprazoleDRUG

Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status.

Also known as: AAPD
Control GroupStudy Group
TandospironeDRUG

Tandospirone，30mg per day

Also known as: Sediel
Study Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic and Statistical Manual of Mental Disorders-IV Edition (DSM-IV) diagnostic criteria for schizophrenia patients.
  • years (including 18 and 65), male or female.
  • Treated with a stable dose of an AAPD for at least three months.
  • Informed consent was obtained (if the patient is in the acute phase of schizophrenia, does not have the capacity, their guardians need sign informed consent).
  • PANSS negative score ≤60.

You may not qualify if:

  • Combined AxisⅠmental illness other than schizophrenia;
  • Taking a mood stabilizer, antidepressants, anticholinergic or anxiolytic drugs, and other drugs improve cognitive function;
  • Suicidal tendencies;
  • Have severe or unstable heart, liver, kidney, endocrine, blood and other medical disease patients
  • Clinically significant ECG or laboratory abnormalities were
  • Glaucoma and epilepsy;
  • Unsupervised or unable to take prescribed medication;
  • History of alcohol and drug abuse;
  • Allergic;
  • Pregnant or lactating woman;
  • Patients participate in other clinical trials during a month;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Psychiatric Hospital

Guangzhou, Guangdong, 510170, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidonetandospirone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Qingyun Yin

    Guangzhou Psychiatric Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingyun Yin

CONTACT

qingyun2000@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 20, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

CN(1)