SchizophreniaPhase 4NCT01149577
Effect of Olanzapine on Sleep Electroencephalogram (EEG) in Schizophrenia Patients
A Phase 4 study testing Olanzapine in people with Schizophrenia and Sleep, run by Central Institute of Psychiatry, Ranchi, India at 1 site in India.
Trial summary
Acute and sub-chronic administration of olanzapine has shown a favourable effect on the sleep disturbances in previously medicated schizophrenia patients with predominantly negative symptoms. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Schizophrenia, Sleep
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2007to Apr 2009
- 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 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients fulfilling International Classification of Diseases-10 Diagnostic Criteria for Research for schizophrenia
- Aged 18-50 Yrs
- Drug naïve or drug free (not receiving any psychotropic medication for the past 4 months)
- Consenting
Who cannot join
- Any comorbid psychiatric illness
- Significant medical or neurological illness
- History of significant head injury, epilepsy
- Substance use in the past 4 months excluding nicotine and caffeine
- Presence of a primary sleep disorder
Trial locations and contacts
1 site in 1 country.
About this study
Acute and sub-chronic administration of olanzapine has shown a favourable effect on the sleep disturbances in previously medicated schizophrenia patients with predominantly negative symptoms. The present study will be carried out to clarify the effect of olanzapine on polysomnographic profiles of schizophrenia patients in an acute phase of illness after controlling for the drug effects.
Read the detailed description
Twenty schizophrenia patients (11 drug naïve and 9 drug free) will be studied over a period of six weeks of olanzapine treatment. Patients will be assessed at the baseline on BPRS, PANSS, CDSS and UKU side effect rating scales and a baseline 40 channels polysomnography will be done. After the initial assessment, patients will put on olanzapine treatment, in flexible dosages based on clinical response, for a period of six weeks when a final assessment on clinical rating scales and polysomnography will be done. The sleep data will be scored manually for staging based on Rechtschaffen and Kales criteria.
- Conditions
- Schizophrenia, Sleep
- Being tested
- Olanzapine
- Keywords
- Olanzapine, Schizophrenia, Polysomnography, Slow wave sleep
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
06 weeks treatment with Olanzapine in a flexible dosage schedule.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia patients | Experimental | The study population of 25 schizophrenia patients constituted the active arm of the study. Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep EEG
Changes in Sleep EEG parameters like Total sleep time, total sleep period, sleep efficiency, sleep latency, stage shifts, stage 1 shifts, stage 1 parameters, stage 2 parameters, stage 3 parameters, stage 4 parameters, rapid eye movement (REM) parameters.
Measured: 06 weeks
Secondary outcomes (1)
Psychopathology
Changes in psychopathological scores as measured by Brief Psychiatric Rating Scale (BPRS) and Positive and Negative Syndrome Scale (PANSS).
Measured: 06 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionApr 2009
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Psychiatry, Ranchi, India
- Sponsor type
- University, hospital or other
- Investigators
- Mohammad Zia Ul Haq Katshu, DPM, Principal investigator, Central Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149577
- Sponsor's protocol ID
- SCHOLZ0003
- Status last verified
- Jun 2010
- First submitted
- 18 Jun 2010
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Olanzapine on Sleep Electroencephalogram (EEG) in Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT01149577
- Acronym / sponsor ID
- SCHOLZ0003
- Conditions
- Schizophrenia, Sleep
- Keywords
- Olanzapine, Schizophrenia, Polysomnography, Slow wave sleep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Central Institute of Psychiatry, Ranchi, IndiaUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 23 Jun 2010 (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.
Acute and sub-chronic administration of olanzapine has shown a favourable effect on the sleep disturbances in previously medicated schizophrenia patients with predominantly negative symptoms. The present study will be carried out to clarify the effect of olanzapine on polysomnographic profiles of schizophrenia patients in an acute phase of illness after controlling for the drug effects.
Detailed description
Twenty schizophrenia patients (11 drug naïve and 9 drug free) will be studied over a period of six weeks of olanzapine treatment. Patients will be assessed at the baseline on BPRS, PANSS, CDSS and UKU side effect rating scales and a baseline 40 channels polysomnography will be done. After the initial assessment, patients will put on olanzapine treatment, in flexible dosages based on clinical response, for a period of six weeks when a final assessment on clinical rating scales and polysomnography will be done. The sleep data will be scored manually for staging based on Rechtschaffen and Kales criteria.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia patients | Experimental | Drug: OlanzapineThe study population of 25 schizophrenia patients constituted the active arm of the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male patients fulfilling International Classification of Diseases-10 Diagnostic Criteria for Research for schizophrenia
- Aged 18-50 Yrs
- Drug naïve or drug free (not receiving any psychotropic medication for the past 4 months)
- Consenting
Key exclusion criteria (5 listed)
- Any comorbid psychiatric illness
- Significant medical or neurological illness
- History of significant head injury, epilepsy
- Substance use in the past 4 months excluding nicotine and caffeine
- Presence of a primary sleep disorder
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 |
|---|---|---|
| Olanzapine06 weeks treatment with Olanzapine in a flexible dosage schedule. | Drug | Schizophrenia patients |
Primary outcome
Sleep EEG
Time frame: 06 weeks
Changes in Sleep EEG parameters like Total sleep time, total sleep period, sleep efficiency, sleep latency, stage shifts, stage 1 shifts, stage 1 parameters, stage 2 parameters, stage 3 parameters, stage 4 parameters, rapid eye movement (REM) parameters.
1 secondary outcome
Psychopathology
Time frame: 06 weeks
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 23 Jun 2010.
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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.
Mohammad Zia Ul Haq Katshu, DPM principal investigator
Central Institute of Psychiatry
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 Olanzapine in people with Schizophrenia and Sleep, run by Central Institute of Psychiatry, Ranchi, India at 1 site in India.
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 4 inclusion and 5 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 23 Jun 2010. 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 India. 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?
Sleep EEG (time frame: 06 weeks). 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 23 Jun 2010.