SchizophreniaPhase 4NCT02199743
Lurasidone Effects on Tissue Glutamate in Schizophrenia
A Phase 4 study testing Lurasidone, Haloperidol and Perphenazine in people with Schizophrenia and Schizoaffective Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
24 individuals with schizophrenia or schizoaffective disorders, who are currently considered stable, will be recruited, screened for entry criteria into a blinded study with a 4-week randomization to either lurasidone, haloperidol, or perphenazine to examine glutamate-related outcomes with lurasidone as compared to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Lurasidone, Haloperidol and Perphenazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2016
- Phase
- Phase 4
- 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
- Subject at least 18 years old
- Subject meets criteria diagnosis of schizophrenia or schizoaffective disorder.
- Subject is not pregnant and is not planning pregnancy within the projected duration of the study.
- Female subject who is of reproductive potential agrees to remain abstinent or use adequate and reliable contraception throughout the study
- Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
- Eyesight corrected to 20-40 or better
- Able to read, speak, and understand English*
Who cannot join
- Any medications being used as mood stabilizers (i.e., anticonvulsants)
- Subject currently has a clinically significant medical condition(s) that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study.
- Subject demonstrates evidence of acute/chronic hepatitis which is clinically significant
- Subject has a history of malignancy < 5 years prior
- Subject has a history of neuroleptic malignant syndrome (NMS).
- Subject has a history of alcohol or substance abuse within 3 months prior to screening or alcohol or substance dependence within 12 months prior to screening
Show all 18Show fewer
- Subject tests positive for drugs of abuse at screening. In the event a subject tests positive for cannabis, the investigator will evaluate the subject's ability to abstain from cannabis during the study.
- Subjects diagnosed with type 1 diabetes
- Subject has a prolactin concentration > 200 ng/mL at screening
- Subject has a history or presence of abnormal ECG which is clinically significant
- Subject has a history of hypersensitivity to more than two distinct chemical classes of drug (e.g., sulfas and penicillins).
- Subjects have received depot neuroleptics within 12 weeks prior to randomization.
- Subject has a history of treatment with clozapine for refractory psychosis and/or subject has been treated with clozapine within 4 months of randomization.
- Subject does not have a stable residence for the 3 months prior to randomization.
- Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study.
- Subject has received electroconvulsive therapy (ECT) within 90 days prior to
- Subject has been randomized in a prior clinical trial of lurasidone.
- History of serious head injury with unconsciousness for >30 minutes
Trial locations and contacts
1 site in 1 country.
About this study
24 individuals with schizophrenia or schizoaffective disorders, who are currently considered stable, will be recruited, screened for entry criteria into a blinded study with a 4-week randomization to either lurasidone, haloperidol, or perphenazine to examine glutamate-related outcomes with lurasidone as compared to haloperidol and perphenazine.
Read the detailed description
At study start all volunteers will be discontinued from their current antipsychotic drug (APD) and switched to haloperidol 4mg for 5 days. At the end of this discontinuation period, all baseline symptom ratings and cognition testing will be done, as well as the baseline imaging procedures. At the end of the baseline procedures, volunteers will be blindly randomized, either to lurasidone at 40mg (N=12), or to haloperidol at 4mg/d or perphenazine at 16mg/d (N=12). Doses will increase to 80mg/d lurasidone, 8 mg/d haloperidol, or 32 mg/d of perphenazine at the beginning of week two. Dose should be stable for the last 3 weeks of treatment unless side effects are prominent, then the dose can be decreased to 40 lurasidone/4 haloperidol/16 perphenazine mg/d for optimal clinical management. The randomization strategy will be designed and implemented by the research pharmacist in four blocks of six volunteers; drug will be dispensed by the research pharmacy according to the randomization schedule. The randomization will be followed by a four week treatment period at optimal dose levels. On the last two days of the 4 week stable dosing period, the specified glutamate outcome measures will be completed (neuroimaging and cognitive testing) along with all the symptom outcome measures, testing for drug plasma levels, and usual blood safety measures. Patients will be seen weekly for clinical evaluation; suicidality will be monitored weekly. All medications other than study drugs will be discontinued, as much as possible, for the 24-48 hr assessment period. After the evaluation phase, patients will be cross-titrated back to their original treatment medication and dosing.
This design will generate outcomes from 12 patients on lurasidone vs. 12 patients on haloperidol/ perphenazine.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Lurasidone, Haloperidol, Perphenazine
- Keywords
- schizophrenia, schizoaffective, cognition, lurasidone, Latuda
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Also called Latuda
Compare to haloperidol and perphenazine
HaloperidolDrug
Also called Haldol
Compare to lurasidone
PerphenazineDrug
Also called Trilafon
Compare to lurasidone
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone | Active comparator | Lurasidone 40mg po qhs with food x 1 week; Lurasidone 80mg po qhs with food x 3 weeks Receives: Drug: Lurasidone; Drug: Haloperidol; Drug: Perphenazine |
| Haloperidol | Active comparator | Haloperidol 4mg po qhs with food x 1 week; Haloperidol 8mg po qhs with food x 3 weeks. Receives: Drug: Lurasidone; Drug: Haloperidol; Drug: Perphenazine |
| Perphenazine | Active comparator | Perphenazine 16mg po qhs with food x 1 week; Perphenazine 32mg po qhs with food x 3 weeks. Receives: Drug: Lurasidone; Drug: Haloperidol; Drug: Perphenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Glutamate Levels
Mean values of cerebral glutamate levels was measured by high resolution 3T magnetic resonance spectroscopy (MRS) in the anterior cingulate cortex (ACC). Data were acquired from the dorsal anterior cingulate cortex (ACC) using single voxel localized PRESS (TE1, TE2) = (32, 65) ms with an 8-channel head coil in a 3T whole-body scanner (Philips Medical Systems). Voxel size was 30x20x15 mm3 (9 mL) and were placed over the bilateral anterior cingulate cortex (ACC). All values are normalized to water.
More negative values represent less cerebral glutamate levels.
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Brief Assessments of Cognition in Schizophrenia Scores (BACS)
Mean of cognition was assessed by BACS, which measures neurocognitive function in schizophrenia. BACs is a validated, composite measure of cognition which is used in schizophrenia. It is composed of Verbal memory (range: 0-75), Working memory (range: 0-28), Motor speed (range: 0-100), Verbal Fluency (number of words generated), Information processing (range: 0-110) and Executive functions (range: 0-22).
Higher z-scores indicate a better performance and outcome. BACS composite score are represented as z-scores which can be positive or negative. There is no minimum or maximum as this is a continuous measure.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completionJun 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Principal investigator, Carol A. Tamminga, University of Texas Southwestern Medical Center
- Investigators
- Carol A Tamminga, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199743
- Sponsor's protocol ID
- STU 032012-053
- Status last verified
- Feb 2021
- First submitted
- 23 Jul 2014
- Last updated
- 1 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Storman D, Koperny M, Styczen K, Datka W, Jaeschke RR. Lurasidone versus typical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2025 Jan 20;1(1):CD012429. doi: 10.1002/14651858.CD012429.pub2.
PubMed 39831535
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lurasidone Effects on Tissue Glutamate in Schizophrenia
- ClinicalTrials.gov ID
- NCT02199743
- Acronym / sponsor ID
- STU 032012-053
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, schizoaffective, cognition, lurasidone, Latuda
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Posted 1 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
24 individuals with schizophrenia or schizoaffective disorders, who are currently considered stable, will be recruited, screened for entry criteria into a blinded study with a 4-week randomization to either lurasidone, haloperidol, or perphenazine to examine glutamate-related outcomes with lurasidone as compared to haloperidol and perphenazine.
Detailed description
At study start all volunteers will be discontinued from their current antipsychotic drug (APD) and switched to haloperidol 4mg for 5 days. At the end of this discontinuation period, all baseline symptom ratings and cognition testing will be done, as well as the baseline imaging procedures. At the end of the baseline procedures, volunteers will be blindly randomized, either to lurasidone at 40mg (N=12), or to haloperidol at 4mg/d or perphenazine at 16mg/d (N=12). Doses will increase to 80mg/d lurasidone, 8 mg/d haloperidol, or 32 mg/d of perphenazine at the beginning of week two. Dose should be stable for the last 3 weeks of treatment unless side effects are prominent, then the dose can be decreased to 40 lurasidone/4 haloperidol/16 perphenazine mg/d for optimal clinical management. The randomization strategy will be designed and implemented by the research pharmacist in four blocks of six volunteers; drug will be dispensed by the research pharmacy according to the randomization schedule. The randomization will be followed by a four week treatment period at optimal dose levels. On the last two days of the 4 week stable dosing period, the specified glutamate outcome measures will be completed (neuroimaging and cognitive testing) along with all the symptom outcome measures, testing for drug plasma levels, and usual blood safety measures. Patients will be seen weekly for clinical evaluation; suicidality will be monitored weekly. All medications other than study drugs will be discontinued, as much as possible, for the 24-48 hr assessment period. After the evaluation phase, patients will be cross-titrated back to their original treatment medication and dosing.
This design will generate outcomes from 12 patients on lurasidone vs. 12 patients on haloperidol/ perphenazine.
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 | Active comparator | Drug: Lurasidone, Drug: Haloperidol, Drug: PerphenazineLurasidone 40mg po qhs with food x 1 week; Lurasidone 80mg po qhs with food x 3 weeks |
| Haloperidol | Active comparator | Drug: Lurasidone, Drug: Haloperidol, Drug: PerphenazineHaloperidol 4mg po qhs with food x 1 week; Haloperidol 8mg po qhs with food x 3 weeks. |
| Perphenazine | Active comparator | Drug: Lurasidone, Drug: Haloperidol, Drug: PerphenazinePerphenazine 16mg po qhs with food x 1 week; Perphenazine 32mg po qhs with food x 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject at least 18 years old
- Subject meets criteria diagnosis of schizophrenia or schizoaffective disorder.
- Subject is not pregnant and is not planning pregnancy within the projected duration of the study.
- Female subject who is of reproductive potential agrees to remain abstinent or use adequate and reliable contraception throughout the study
- Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
Key exclusion criteria (18 listed)
- Any medications being used as mood stabilizers (i.e., anticonvulsants)
- Subject currently has a clinically significant medical condition(s) that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study.
- Subject demonstrates evidence of acute/chronic hepatitis which is clinically significant
- Subject has a history of malignancy < 5 years prior
- Subject has a history of neuroleptic malignant syndrome (NMS).
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 |
|---|---|---|
| LurasidoneAlso: LatudaCompare to haloperidol and perphenazine | Drug | Haloperidol, Lurasidone, Perphenazine |
| HaloperidolAlso: HaldolCompare to lurasidone | Drug | Haloperidol, Lurasidone, Perphenazine |
| PerphenazineAlso: TrilafonCompare to lurasidone | Drug | Haloperidol, Lurasidone, Perphenazine |
Primary outcome
Cerebral Glutamate Levels
Time frame: Baseline and 4 weeks
Mean values of cerebral glutamate levels was measured by high resolution 3T magnetic resonance spectroscopy (MRS) in the anterior cingulate cortex (ACC). Data were acquired from the dorsal anterior cingulate cortex (ACC) using single voxel localized PRESS (TE1, TE2) = (32, 65) ms with an 8-channel head coil in a 3T whole-body scanner (Philips Medical Systems). Voxel size was 30x20x15 mm3 (9 mL) and were placed over the bilateral anterior cingulate cortex (ACC). All values are normalized to water. More negative values represent less cerebral glutamate levels.
1 secondary outcome
Brief Assessments of Cognition in Schizophrenia Scores (BACS)
Time frame: Baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39831535Storman D, Koperny M, Styczen K, Datka W, Jaeschke RR. Lurasidone versus typical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2025 Jan 20;1(1):CD012429. doi: 10.1002/14651858.CD012429.pub2.
- Tamminga Lab and Clinic WebsiteLink provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Carol A Tamminga, M.D. principal investigator
University of Texas Southwestern Medical Center
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 Lurasidone, Haloperidol and Perphenazine in people with Schizophrenia and Schizoaffective Disorder, run by University of Texas Southwestern Medical Center 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 7 inclusion and 18 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 1 Mar 2021. 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 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?
Yes. Results are posted in the registry (first posted 1 Mar 2021). 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?
Cerebral Glutamate Levels (time frame: Baseline and 4 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 NCT02199743, 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 1 Mar 2021.