SchizophreniaPhase 4NCT02704962

Olanzapine vs. Low-dose Olanzapine Plus Trifluoperazine

A Phase 4 study testing full-dose olanzapine in people with Schizophrenia, run by Kaohsiung Kai-Suan Psychiatric Hospital at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators hypothesis is that an antipsychotic drug combination of low-dose olanzapine plus low-dose trifluoperazine is similar to regular-dose olanzapine monotherapy in efficacy and safety for treatment of schizophrenia.The goal of this study is to compare the efficacy and safety of the olanzapine (10 mg/d)… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Schizophrenia
What is being tested?: full-dose olanzapine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 2 sitesTaiwan
Study dates: Jan 2012to Feb 2016
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

were physically healthy and had all laboratory parameters within normal limits
were aged 18 to 55 years
satisfied the DSM-IV criteria for schizophrenia
had baseline Clinical Global Impression-Severity of Illness (CGI-S) scale score of 4 or greater
had no DSM-IV diagnosis of substance abuse or dependence (including alcohol)
had not received depot antipsychotic drugs for the preceding 3 months
gave written informed consent to participate in the study after a full explanation of the study's aims and procedures.

Who cannot join

those with a history of serious adverse reaction to olanzapine or trifluoperazine or a history of tardive dyskinesia or neuroleptic malignant syndrome
female subjects who were pregnant or at risk for pregnancy or lactation
those that had a diagnosis of treatment-resistant schizophrenia or having previously received clozapine or electroconvulsive therapy

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

Kai-Suan Psychiatric Hospital
Kaohsiung City, 802
Kai-Suan Psychiatric Hospital
Kaohsiung City

Other trials in Taiwan

About this study

Official title: A Randomized, Double-blind, Comparison of the Efficacy and Safety of Olanzapine Versus Low-dose Olanzapine Plus Low-dose Trifluoperazine in the Treatment of Schizophrenia

Read the detailed description

Antipsychotic monotherapy is recognized as the treatment of choice for patients with schizophrenia. Surveys have shown that antipsychotic polypharmacy are frequently prescribed, yet few randomized, double-blind clinical trials have examined this practice. Olanzapine, an atypical antipsychotic agent, has low incidence of extrapyramidal symptom but with high cost compared to trifluoperazine. It has been reported that mean doses of typical antipsychotics less than 600 mg per day of chlorpromazine or its equivalent has no higher risk of extrapyramidal symptom than atypical antipsychotics. The objective of the study is to compare the efficacy and safety of the olanzapine (10 mg per day) and olanzapine (5 mg per day) plus trifluoperazine (5 mg per day) in the treatment of acute psychotic exacerbations of schizophrenia. In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are randomly assigned to olanzapine (10 mg per day)) or olanzapine (5 mg per day) plus trifluoperazine (5 mg per day). The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost. The primary efficacy measure is change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores; secondary outcomes include Clinical Global Impression-Severity (CGI-S), the Calgary Depression Scale for Schizophrenia (CDSS), Global Assessment of Functioning Scale (GAF), Short Form-36 (SF-36), Mini Mental State Examination (MMSE). Safety assessments include the change from baseline on Simpson-Angus Rating Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BAS), and UKU Side-effects Rating Scale, and the change from baseline in prolactin levels, body weight, vital sign, blood pressure, Bazett's correction of QT interval (QTc interval), fasting glucose level, and lipid panel (cholesterol, high density lipid protein, low density lipid protein, and triglyceride).

Conditions: Schizophrenia
Being tested: full-dose olanzapine
Keywords: schizophrenia, olanzapine, trifluoperazine, antipsychotic polypharmacy
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

full-dose olanzapineDrug
Also called polypharmacy
trifluoperazine 5mg/d

Study groups in NCT02704962
Study group	Role	What they receive
trifluoperazine plus olanzapine	Experimental	trifluoperazine 5mg/day + olanzapine 5mg/day Receives: Drug: full-dose olanzapine
full-dose olanzapine	Active comparator	olanzapine 10mg/day Receives: Drug: full-dose olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

The changes in the Positive and Negative Syndrome Scale (PANSS) scores from baseline to the end of the study.
Measured: The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).

Secondary outcomes (17)

The changes in the Clinical Global Impression-Severity (CGI-S) scores from baseline to the end of the study.
Measured: The CGI-S was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Calgary Depression Scale for Schizophrenia (CDSS) scores from baseline to the end of the study.
Measured: The CDSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Global Assessment of Functioning (GAF) scores from baseline to the end of the study.
Measured: The GAF was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Short-Form 36 (SF-36) scores from baseline to week 6.
Measured: The SF-36 was rated at baseline and again at week 6.
The changes in the Mini Mental State Examination (MMSE) scores from baseline to week 6.
Measured: The MMSE was rated at baseline and again at week 6.
The changes in the Simpson-Angus Rating Scale (SAS) scores from baseline to the end of the study.
Measured: The SAS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Abnormal Involuntary Movement Scale (AIMS) scores from baseline to the end of the study.
Measured: The AIMS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Barnes Akathisia Scale (BAS) scores from baseline to the end of the study.
Measured: The BAS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the UKU Side-effects Rating Scale (UKU) scores from baseline to the end of the study.
Measured: The UKU was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Bazett's correction of QT interval (QTc interval) from baseline to week 6.
Measured: The QTc interval was assayed at baseline and again at week 6.
The changes in the body weight from baseline to the end of the study.
Measured: The body weight was assayed at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the fasting glucose level from baseline to week 6.
Measured: The fasting glucose level was assayed at baseline and again at week 6.
The changes in the prolactin level from baseline to week 6.
Measured: The prolactin level was assayed at baseline and again at week 6.
The changes in the cholesterol level from baseline to week 6.
Measured: The cholesterol level was assayed at baseline and again at week 6.
The changes in the high density lipoprotein (HDL) level from baseline to week 6.
Measured: The HDL level was assayed at baseline and again at week 6.
The changes in the low density lipoprotein (LDL) level from baseline to week 6.
Measured: The LDL level was assayed at baseline and again at week 6.
The changes in the triglyceride level from baseline to week 6.
Measured: The triglyceride level was assayed at baseline and again at week 6.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Feb 2016

First posted10 Mar 2016 (estimated)
Study startJan 2012
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02704962
Sponsor's protocol ID: KSPH-2011-22
Status last verified: Mar 2016
First submitted: 27 Feb 2016
Last updated: 10 Mar 2016
Results posted: No
Data monitoring committee: Yes

Publications

Lin CH, Wang FC, Lin SC, Huang YH, Chen CC, Lane HY. Antipsychotic combination using low-dose antipsychotics is as efficacious and safe as, but cheaper, than optimal-dose monotherapy in the treatment of schizophrenia: a randomized, double-blind study. Int Clin Psychopharmacol. 2013 Sep;28(5):267-74. doi: 10.1097/YIC.0b013e3283633a83.
PubMed 23778382
Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet. 2009 Jan 3;373(9657):31-41. doi: 10.1016/S0140-6736(08)61764-X. Epub 2008 Dec 6.
PubMed 19058842
Lin CH, Kuo CC, Chou LS, Chen YH, Chen CC, Huang KH, Lane HY. A randomized, double-blind comparison of risperidone versus low-dose risperidone plus low-dose haloperidol in treating schizophrenia. J Clin Psychopharmacol. 2010 Oct;30(5):518-25. doi: 10.1097/JCP.0b013e3181f28dff.
PubMed 20814315

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Comparison of the Efficacy and Safety of Olanzapine Versus Low-dose Olanzapine Plus Low-dose Trifluoperazine in the Treatment of Schizophrenia
ClinicalTrials.gov ID: NCT02704962
Acronym / sponsor ID: KSPH-2011-22
Conditions: Schizophrenia
Keywords: schizophrenia, olanzapine, trifluoperazine, antipsychotic polypharmacy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Kaohsiung Kai-Suan Psychiatric HospitalOther government
Collaborators: Department of Health, Executive Yuan, R.O.C. (Taiwan)
Study start: Jan 2012
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 10 Mar 2016 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
trifluoperazine plus olanzapine	Experimental	Drug: full-dose olanzapinetrifluoperazine 5mg/day + olanzapine 5mg/day
full-dose olanzapine	Active comparator	Drug: full-dose olanzapineolanzapine 10mg/day

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

were physically healthy and had all laboratory parameters within normal limits
were aged 18 to 55 years
satisfied the DSM-IV criteria for schizophrenia
had baseline Clinical Global Impression-Severity of Illness (CGI-S) scale score of 4 or greater
had no DSM-IV diagnosis of substance abuse or dependence (including alcohol)

Key exclusion criteria (3 listed)

those with a history of serious adverse reaction to olanzapine or trifluoperazine or a history of tardive dyskinesia or neuroleptic malignant syndrome
female subjects who were pregnant or at risk for pregnancy or lactation
those that had a diagnosis of treatment-resistant schizophrenia or having previously received clozapine or electroconvulsive therapy

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
full-dose olanzapineAlso: polypharmacytrifluoperazine 5mg/d	Drug	full-dose olanzapine, trifluoperazine plus olanzapine

Primary outcome

The changes in the Positive and Negative Syndrome Scale (PANSS) scores from baseline to the end of the study.
Time frame: The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).

17 secondary outcomes

The changes in the Clinical Global Impression-Severity (CGI-S) scores from baseline to the end of the study.
Time frame: The CGI-S was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Calgary Depression Scale for Schizophrenia (CDSS) scores from baseline to the end of the study.
Time frame: The CDSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Global Assessment of Functioning (GAF) scores from baseline to the end of the study.
Time frame: The GAF was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Short-Form 36 (SF-36) scores from baseline to week 6.
Time frame: The SF-36 was rated at baseline and again at week 6.
The changes in the Mini Mental State Examination (MMSE) scores from baseline to week 6.
Time frame: The MMSE was rated at baseline and again at week 6.
The changes in the Simpson-Angus Rating Scale (SAS) scores from baseline to the end of the study.
Time frame: The SAS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Abnormal Involuntary Movement Scale (AIMS) scores from baseline to the end of the study.
Time frame: The AIMS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Barnes Akathisia Scale (BAS) scores from baseline to the end of the study.
Time frame: The BAS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the UKU Side-effects Rating Scale (UKU) scores from baseline to the end of the study.
Time frame: The UKU was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the Bazett's correction of QT interval (QTc interval) from baseline to week 6.
Time frame: The QTc interval was assayed at baseline and again at week 6.
The changes in the body weight from baseline to the end of the study.
Time frame: The body weight was assayed at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).
The changes in the fasting glucose level from baseline to week 6.
Time frame: The fasting glucose level was assayed at baseline and again at week 6.
The changes in the prolactin level from baseline to week 6.
Time frame: The prolactin level was assayed at baseline and again at week 6.
The changes in the cholesterol level from baseline to week 6.
Time frame: The cholesterol level was assayed at baseline and again at week 6.
The changes in the high density lipoprotein (HDL) level from baseline to week 6.
Time frame: The HDL level was assayed at baseline and again at week 6.
The changes in the low density lipoprotein (LDL) level from baseline to week 6.
Time frame: The LDL level was assayed at baseline and again at week 6.
The changes in the triglyceride level from baseline to week 6.
Time frame: The triglyceride level was assayed at baseline and again at week 6.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
Background: PubMed 23778382Lin CH, Wang FC, Lin SC, Huang YH, Chen CC, Lane HY. Antipsychotic combination using low-dose antipsychotics is as efficacious and safe as, but cheaper, than optimal-dose monotherapy in the treatment of schizophrenia: a randomized, double-blind study. Int Clin Psychopharmacol. 2013 Sep;28(5):267-74. doi: 10.1097/YIC.0b013e3283633a83.
Results publication: PubMed 19058842Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet. 2009 Jan 3;373(9657):31-41. doi: 10.1016/S0140-6736(08)61764-X. Epub 2008 Dec 6.
Results publication: PubMed 20814315Lin CH, Kuo CC, Chou LS, Chen YH, Chen CC, Huang KH, Lane HY. A randomized, double-blind comparison of risperidone versus low-dose risperidone plus low-dose haloperidol in treating schizophrenia. J Clin Psychopharmacol. 2010 Oct;30(5):518-25. doi: 10.1097/JCP.0b013e3181f28dff.

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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.

Ching-Hua Lin, MD, PhD principal investigator

Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung City, Taiwan

Cheng-Chung Cheng, MD, PhD study chair

Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung City, Taiwan

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing full-dose olanzapine in people with Schizophrenia, run by Kaohsiung Kai-Suan Psychiatric Hospital at 2 sites in Taiwan.

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 7 inclusion and 3 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: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The changes in the Positive and Negative Syndrome Scale (PANSS) scores from baseline to the end of the study. (time frame: The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02704962, which also lists 3 linked publications.

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 10 Mar 2016.