SchizophreniaPhase 4TAASNCT02040883
Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia
A Phase 4 study testing Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole and Tandospirone in people with Schizophrenia, run by Qingyun Yin at 1 site in China.
Trial summary
Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve Cognitive function in Schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole and Tandospirone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic and Statistical Manual of Mental Disorders-IV Edition (DSM-IV) diagnostic criteria for schizophrenia patients.
- 18-65 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
Qingyun Yin contact
China1 site
Guangzhou Psychiatric Hospital
Guangzhou, Guangdong, 510170
qingyun Yin, qingyun2000@hotmail.com
About this study
Official title: Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia
Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve Cognitive function in Schizophrenia
Read the detailed description
With atypical antipsychotics for the control group, evaluate cognitive function in schizophrenia patients with antipsychotics combined 5-Hydroxytryptamine 1A (5-HT1A) receptor partial agonist tandospirone
- Conditions
- Schizophrenia
- Being tested
- Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole, Tandospirone
- Keywords
- Schizophrenia, Tandospirone, Cognitive Therapy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone/Olanzapine/Quetiapine/Ziprasidone/AripiprazoleDrug
Also called AAPD
Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status.
TandospironeDrug
Also called Sediel
Tandospirone，30mg per day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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; Receives: Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole; Drug: Tandospirone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score
Measured: From baseline to 12 weeks of treatment
Secondary outcomes (7)
MATRICS Consensus Cognitive Battery(MCCB) factor score
Measured: From baseline to 12 weeks of treatment
Positive and Negative Syndrome Scale(PANSS) total score
Measured: From baseline to 12 weeks of treatment
Positive and Negative Syndrome Scale(PANSS) factor score
Measured: From baseline to 12 weeks of treatment
Personal and Social Performance Scale(PSP) total score
Measured: From baseline to 12 weeks of treatment
Clinical Global Impression(CGI) factor score
Measured: From baseline to 12 weeks of treatment
Treatment Emergent Symptom Scale(TESS) factor score
Measured: From baseline to 12 weeks of treatment
Functional magnetic resonance imaging(FMRI)
Measured: From baseline to 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingyun Yin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Qingyun Yin, Guangzhou Psychiatric Hospital
- Investigators
- Qingyun Yin, Principal investigator, Guangzhou Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040883
- Sponsor's protocol ID
- DSPC-SED20130516
- Acronym
- TAAS
- Status last verified
- Jan 2014
- First submitted
- 14 Jan 2014
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia
- ClinicalTrials.gov ID
- NCT02040883
- Acronym / sponsor ID
- TAAS / DSPC-SED20130516
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Tandospirone, Cognitive Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qingyun YinOther government
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve Cognitive function in Schizophrenia
Detailed description
With atypical antipsychotics for the control group, evaluate cognitive function in schizophrenia patients with antipsychotics combined 5-Hydroxytryptamine 1A (5-HT1A) receptor partial agonist tandospirone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/AripiprazoleTreated with a stable dose of an AAPD for at least three months before enrollment; Atypical antipsychotic drugs(AAPDs): Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole |
| Study Group | Experimental | Drug: Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole, Drug: TandospironeAtypical 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; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnostic and Statistical Manual of Mental Disorders-IV Edition (DSM-IV) diagnostic criteria for schizophrenia patients.
- 18-65 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone/Olanzapine/Quetiapine/Ziprasidone/AripiprazoleAlso: AAPDTreated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status. | Drug | Control Group, Study Group |
| TandospironeAlso: SedielTandospirone，30mg per day | Drug | Study Group |
Primary outcome
Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score
Time frame: From baseline to 12 weeks of treatment
7 secondary outcomes
MATRICS Consensus Cognitive Battery(MCCB) factor score
Time frame: From baseline to 12 weeks of treatment
Positive and Negative Syndrome Scale(PANSS) total score
Time frame: From baseline to 12 weeks of treatment
Positive and Negative Syndrome Scale(PANSS) factor score
Time frame: From baseline to 12 weeks of treatment
Personal and Social Performance Scale(PSP) total score
Time frame: From baseline to 12 weeks of treatment
Clinical Global Impression(CGI) factor score
Time frame: From baseline to 12 weeks of treatment
Treatment Emergent Symptom Scale(TESS) factor score
Time frame: From baseline to 12 weeks of treatment
Functional magnetic resonance imaging(FMRI)
Time frame: From baseline to 12 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingyun Yin contact
Qingyun Yin principal investigator
Guangzhou Psychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole and Tandospirone in people with Schizophrenia, run by Qingyun Yin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingyun Yin (qingyun2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement and treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery(MCCB) total score (time frame: From baseline to 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2014.