SchizophreniaNCT00642369
A 4-week, Randomized, Rater-blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia
A study testing quetiapine fumarate and haloperidol in people with Schizophrenia, run by Guang Dong Provincial Mental Health Institute at 1 site in China.
Trial summary
This study will apply polysomnography (PSG) to evaluate the effect of quetiapine fumarate on sleep architecture. Most of previous studies evaluated sleep by self-reported questionnaires during the antipsychotic treatment (clozapine, risperidone, olanzapine, et al), while only a few studies with PSG evaluation had some… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- quetiapine fumarate and haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Oct 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- For inclusion in the study patients must fulfill all of the following criteria:
- Provision of written informed consent by patient or his/her legal guardian
- Hospitalized for a diagnosis of Schizophrenia paranoid subtype by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Positive and Negative Syndrome Scale (PANSS) total score≥60
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chronic gonadotropin (HCG) test at enrolment
- Able to understand and comply with the requirements of the study
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate or/and haloperidol, as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
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- Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
- Organic changes was founded by brain CT
- Involvement in the planning and conduct of the study
- Previous enrolment or randomisation of treatment in the present study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%; admitted to hospital for treatment of DM or DM related illness in past 12 weeks; not under physician care for DM Physician responsible for patient's DM care has not indicated that patient's DM is controlled; Physician responsible for patient's DM care has not approved patient's participation in the study; has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation; for thiazolidinediones (glitazones) this period should not be less than 8 Weeks; taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks. Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
- An absolute neutrophil count (ANC) of 1.5 x 109/L
- Sleep disorder such as Apnea Hypopneas Syndrome, periodic leg movement syndrome and narcolepsy
- The work time is rotate and/or often flies across the time zone
- Use of clozapine within 28 days prior to randomization
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Mental Health Institute
Guangzhou, Guangdong, 510120
About this study
Official title: Study of Evaluating Quetiapine in Improving Sleep Quality of Schizophrenia
This study will apply polysomnography (PSG) to evaluate the effect of quetiapine fumarate on sleep architecture. Most of previous studies evaluated sleep by self-reported questionnaires during the antipsychotic treatment (clozapine, risperidone, olanzapine, et al), while only a few studies with PSG evaluation had some limitation, such as: small sample size, respective or cross-sectional, potential sleep disorders, et al. In this study, we will investigate both subjective and objective effect of quetiapine fumarate in improving sleep quality in schizophrenic patients by PSG as well as psychiatric scales. The control drug in this study is the typical antipsychotic - haloperidol. It could increase sleep duration and efficiency by mostly increasing the S2 without effect on rapid eye movement (REM) sleep and slow wave sleep (SWS). The patients will be randomised into two groups as a parallel design. This study is designed as rater blinded to reduce the bias in evaluation. It is suggested that the sedative effect of quetiapine fumarate could diminish in 2 weeks, therefore, we use 4 weeks to ensure the change of sleep quality in this study, which could be helpful for the evaluation of relative short and middle term effect of quetiapine fumarate on sleep quality.
Read the detailed description
- The objective sleep structures of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of composite variables for PSG test (sleep stages, time in bed, total sleep time, sleep efficiency, sleep latency) from baseline to Week 4 (LOCF).
- The subjective sleep qualities of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of Pittsburgh Sleep Quality Inventory (PSQI) and Epworth Sleepiness Scale(ESS) from baseline to Week 4 (LOCF).
- The clinical efficacy of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of Positive and Negative Syndrome Scale (PANSS) and Clinical Globe Impression (CGI),and Calgary Depression Scale for Schizophrenia (CDSS) from baseline to Week 4 (LOCF).
- The clinical safety and tolerance quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by Treatment Emergent Symptom Scale (TESS) in day 14 and day 28.
- Conditions
- Schizophrenia
- Being tested
- quetiapine fumarate, haloperidol
- Keywords
- Polysomnograph
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapine fumarateDrug
Also called seroquel
600-750mg/day
haloperidolDrug
6-40mg/day
| Study group | Role | What they receive |
|---|---|---|
| quetiapine fumarate | Experimental | quetiapine fumarate was administered 25mg on the 1st day,738±41mg/day on the 14th day, and 738±48mg/day on the 28th day. Receives: Drug: quetiapine fumarate |
| haloperidol | Active comparator | haloperidol was administered 2mg on the 1st day,16±7mg/day on the 14th day, and 18±6mg/day on the 28th day. Receives: Drug: haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Slow Wave Sleep
The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF).
Measured: 28 days
Percentage of Rapid Eye Movement Sleep
The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang Dong Provincial Mental Health Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Zhang, Guang Dong Provincial Mental Health Institute
- Investigators
- Zhang Bin, Ph. D, Principal investigator, Guang Dong Provincial Mental Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642369
- Sponsor's protocol ID
- D1443L00053
- Status last verified
- Mar 2014
- First submitted
- 18 Mar 2008
- Last updated
- 17 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Evaluating Quetiapine in Improving Sleep Quality of Schizophrenia
- ClinicalTrials.gov ID
- NCT00642369
- Acronym / sponsor ID
- D1443L00053
- Conditions
- Schizophrenia
- Keywords
- Polysomnograph
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guang Dong Provincial Mental Health InstituteUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Posted 17 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will apply polysomnography (PSG) to evaluate the effect of quetiapine fumarate on sleep architecture. Most of previous studies evaluated sleep by self-reported questionnaires during the antipsychotic treatment (clozapine, risperidone, olanzapine, et al), while only a few studies with PSG evaluation had some limitation, such as: small sample size, respective or cross-sectional, potential sleep disorders, et al. In this study, we will investigate both subjective and objective effect of quetiapine fumarate in improving sleep quality in schizophrenic patients by PSG as well as psychiatric scales. The control drug in this study is the typical antipsychotic - haloperidol. It could increase sleep duration and efficiency by mostly increasing the S2 without effect on rapid eye movement (REM) sleep and slow wave sleep (SWS). The patients will be randomised into two groups as a parallel design. This study is designed as rater blinded to reduce the bias in evaluation. It is suggested that the sedative effect of quetiapine fumarate could diminish in 2 weeks, therefore, we use 4 weeks to ensure the change of sleep quality in this study, which could be helpful for the evaluation of relative short and middle term effect of quetiapine fumarate on sleep quality.
Detailed description
- The objective sleep structures of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of composite variables for PSG test (sleep stages, time in bed, total sleep time, sleep efficiency, sleep latency) from baseline to Week 4 (LOCF).
- The subjective sleep qualities of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of Pittsburgh Sleep Quality Inventory (PSQI) and Epworth Sleepiness Scale(ESS) from baseline to Week 4 (LOCF).
- The clinical efficacy of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of Positive and Negative Syndrome Scale (PANSS) and Clinical Globe Impression (CGI),and Calgary Depression Scale for Schizophrenia (CDSS) from baseline to Week 4 (LOCF).
- The clinical safety and tolerance quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by Treatment Emergent Symptom Scale (TESS) in day 14 and day 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quetiapine fumarate | Experimental | Drug: quetiapine fumaratequetiapine fumarate was administered 25mg on the 1st day,738±41mg/day on the 14th day, and 738±48mg/day on the 28th day. |
| haloperidol | Active comparator | Drug: haloperidolhaloperidol was administered 2mg on the 1st day,16±7mg/day on the 14th day, and 18±6mg/day on the 28th day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of written informed consent by patient or his/her legal guardian
- Hospitalized for a diagnosis of Schizophrenia paranoid subtype by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Positive and Negative Syndrome Scale (PANSS) total score≥60
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chronic gonadotropin (HCG) test at enrolment
- Able to understand and comply with the requirements of the study
Key exclusion criteria (21 listed)
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate or/and haloperidol, as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
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 |
|---|---|---|
| quetiapine fumarateAlso: seroquel600-750mg/day | Drug | quetiapine fumarate |
| haloperidol6-40mg/day | Drug | haloperidol |
Primary outcome
Percentage of Slow Wave Sleep
Time frame: 28 days
The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF).
Percentage of Rapid Eye Movement Sleep
Time frame: 28 days
The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Zhang Bin, Ph. D principal investigator
Guang Dong Provincial Mental Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quetiapine fumarate and haloperidol in people with Schizophrenia, run by Guang Dong Provincial Mental Health Institute 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 6 inclusion and 21 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 17 Apr 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Slow Wave Sleep (time frame: 28 days). The study lists 2 primary outcomes in all. 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 17 Apr 2014; AzTrials last refreshed its copy on 31 Oct 2026.