SchizophreniaPhase 3NCT01979679
A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone
A Phase 3 study testing Lurasidone 80 mg, Lurasidone 120 mg and Lurasidone 160 mg in people with Schizophrenia, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this research study is to measure how many of the dopamine receptors lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective disorder and over what time period the occupancy occurs. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lurasidone 80 mg, Lurasidone 120 mg and Lurasidone 160 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Oct 2013
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects are eligible to participate in this study if they:
- are 18 to 60 years of age at the day of first dosing.
- are diagnosed with schizophrenia or schizoaffective disorder.
- are female, subject must be using an acceptable method of birth control or be surgically sterile or postmenopausal. Postmenopausal is defined as no period for at least 12 months. Acceptable methods of birth control include oral, injectable or implanted contraceptives, and barrier methods such as condoms, diaphrams, and spermicides.
- are able to provide written informed consent.
- can safety have an MRI (no metal in the body, not claustrophobic).
Who cannot join
- Subjects are not eligible to participate in this study if they:
- are treatment resisitant or intolerant to lurasidone.
- have had extensive radiation exposure (the study doctor will discuss this with the subject).
- if they have tremors or shaking of the limbs.
- are pregnant or trying to become pregnant or breastfeeding.
- are colorblind.
Show all 9Show fewer
- have a current or past history of a major medical illness or have abnormal lab values which the study doctor feels is significant (any abnormal lab values will be discussed with the subject).
- are taking certain medications. The study doctor will discuss these medicines with the subject.
- have a history of alcohol, cannabis or cocaine abuse within two weeks prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to measure how many of the dopamine receptors lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective disorder and over what time period the occupancy occurs. This is research because lurasidone is an investigational medication that has not yet been approved by the Food and Drug Administration (FDA). Dopamine receptors have key roles in many processes, including the control of motivation, learning, and fine motor movement. The degree of occupancy and the transience of occupancy D2 receptor occupancy for optimal clinical response and to prevent relapses is a controversial area that this study will address.
In this study Positron Emission Tomography (PET) scanning will be performed with D2/D3 ligand 18F-fallypride (a radioactive, injectable substance) to help the researchers measure the use of these receptors. Researchers hope that quantifying the amount of receptors being occupied by the medication will help them to determine the best dose of study medication in terms of improvement and least side effects related to body size and gender as well as in preventing relapse that may be related to hypersensitivity. Magnetic Resonance Imaging (fMRI) will also be performed. MRI is a scanning method which makes pictures of parts of the brain using a large magnetic field. This study will use a particular kind of MRI called fMRI, or functional MRI. fMRI takes pictures of the brain while the person is thinking or doing a simple task. fMRI will allow the researchers to investigate patients regional brain activation during cognitive (mental) and emotional tasks.
- Conditions
- Schizophrenia
- Being tested
- Lurasidone 80 mg, Lurasidone 120 mg, Lurasidone 160 mg
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone 80 mgDrug
Lurasidone 120 mgDrug
Lurasidone 160 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone 80 mg per day | Active comparator | Lurasidone 80 mg per day Receives: Drug: Lurasidone 80 mg |
| Lurasidone 120 mg per day | Active comparator | Lurasidone 120 mg per day Receives: Drug: Lurasidone 120 mg |
| Lurasidone 160 mg per day | Active comparator | Lurasidone 160 mg per day Receives: Drug: Lurasidone 160 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
D2 receptor occupancy
To determine whether additional D2 receptor occupancy can be accomplished with doses of 160 mg of lurasidone per day.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startDec 2008
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Dainippon Sumitomo Pharma America
- Responsible party
- Sponsor
- Investigators
- Steven G Potkin, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979679
- Sponsor's protocol ID
- 2008-6481
- Status last verified
- Nov 2013
- First submitted
- 1 Nov 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Potkin SG, Keator DB, Kesler-West ML, Nguyen DD, van Erp TG, Mukherjee J, Shah N, Preda A. D2 receptor occupancy following lurasidone treatment in patients with schizophrenia or schizoaffective disorder. CNS Spectr. 2014 Apr;19(2):176-81. doi: 10.1017/S109285291300059X. Epub 2013 Sep 30.
PubMed 24073841
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone
- ClinicalTrials.gov ID
- NCT01979679
- Acronym / sponsor ID
- 2008-6481
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Dainippon Sumitomo Pharma America
- Study start
- Dec 2008
- Primary completion
- Oct 2013 (actual)
- First posted
- 8 Nov 2013 (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.
The purpose of this research study is to measure how many of the dopamine receptors lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective disorder and over what time period the occupancy occurs. This is research because lurasidone is an investigational medication that has not yet been approved by the Food and Drug Administration (FDA). Dopamine receptors have key roles in many processes, including the control of motivation, learning, and fine motor movement. The degree of occupancy and the transience of occupancy D2 receptor occupancy for optimal clinical response and to prevent relapses is a controversial area that this study will address.
In this study Positron Emission Tomography (PET) scanning will be performed with D2/D3 ligand 18F-fallypride (a radioactive, injectable substance) to help the researchers measure the use of these receptors. Researchers hope that quantifying the amount of receptors being occupied by the medication will help them to determine the best dose of study medication in terms of improvement and least side effects related to body size and gender as well as in preventing relapse that may be related to hypersensitivity. Magnetic Resonance Imaging (fMRI) will also be performed. MRI is a scanning method which makes pictures of parts of the brain using a large magnetic field. This study will use a particular kind of MRI called fMRI, or functional MRI. fMRI takes pictures of the brain while the person is thinking or doing a simple task. fMRI will allow the researchers to investigate patients regional brain activation during cognitive (mental) and emotional tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lurasidone 80 mg per day | Active comparator | Drug: Lurasidone 80 mgLurasidone 80 mg per day |
| Lurasidone 120 mg per day | Active comparator | Drug: Lurasidone 120 mgLurasidone 120 mg per day |
| Lurasidone 160 mg per day | Active comparator | Drug: Lurasidone 160 mgLurasidone 160 mg per day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- are 18 to 60 years of age at the day of first dosing.
- are diagnosed with schizophrenia or schizoaffective disorder.
- are female, subject must be using an acceptable method of birth control or be surgically sterile or postmenopausal. Postmenopausal is defined as no period for at least 12 months. Acceptable methods of birth control include oral, injectable or implanted contraceptives, and barrier methods such as condoms, diaphrams, and spermicides.
- are able to provide written informed consent.
- can safety have an MRI (no metal in the body, not claustrophobic).
Key exclusion criteria (9 listed)
- are treatment resisitant or intolerant to lurasidone.
- have had extensive radiation exposure (the study doctor will discuss this with the subject).
- if they have tremors or shaking of the limbs.
- are pregnant or trying to become pregnant or breastfeeding.
- are colorblind.
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 |
|---|---|---|
| Lurasidone 80 mg | Drug | Lurasidone 80 mg per day |
| Lurasidone 120 mg | Drug | Lurasidone 120 mg per day |
| Lurasidone 160 mg | Drug | Lurasidone 160 mg per day |
Primary outcome
D2 receptor occupancy
Time frame: Up to 6 weeks
To determine whether additional D2 receptor occupancy can be accomplished with doses of 160 mg of lurasidone per day.
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 8 Nov 2013.
- Results publication: PubMed 24073841Potkin SG, Keator DB, Kesler-West ML, Nguyen DD, van Erp TG, Mukherjee J, Shah N, Preda A. D2 receptor occupancy following lurasidone treatment in patients with schizophrenia or schizoaffective disorder. CNS Spectr. 2014 Apr;19(2):176-81. doi: 10.1017/S109285291300059X. Epub 2013 Sep 30.
Related trials for Schizophrenia
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
RecruitingPhase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
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.
Steven G Potkin, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lurasidone 80 mg, Lurasidone 120 mg and Lurasidone 160 mg in people with Schizophrenia, run by University of California, Irvine at 1 site in United States.
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 9 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 8 Nov 2013. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
D2 receptor occupancy (time frame: Up to 6 weeks). 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 NCT01979679, which also lists 1 linked publication.
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 8 Nov 2013.