Lurasidone Effects on Tissue Glutamate in Schizophrenia

NCT02199743 | Completed Phase 4 Results

• 1 other identifier: STU 032012-053
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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 haloperidol and perphenazine.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; schizoaffective; cognition; lurasidone; Latuda

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 4 weeks

Secondary Outcomes (1)

• Brief Assessments of Cognition in Schizophrenia Scores (BACS)

  Baseline and 4 weeks

Study Arms (3)

Lurasidone

ACTIVE COMPARATOR

Lurasidone 40mg po qhs with food x 1 week; Lurasidone 80mg po qhs with food x 3 weeks

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.

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.

Drug: Lurasidone; Drug: Haloperidol; Drug: Perphenazine

Interventions

Lurasidone DRUG

Compare to haloperidol and perphenazine

Also known as: Latuda

Haloperidol; Lurasidone; Perphenazine

Haloperidol DRUG

Compare to lurasidone

Also known as: Haldol

Haloperidol; Lurasidone; Perphenazine

Perphenazine DRUG

Compare to lurasidone

Also known as: Trilafon

Haloperidol; Lurasidone; Perphenazine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 39831535 DERIVED

Related Links

• Tamminga Lab and Clinic Website

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Lurasidone Hydrochloride; Haloperidol; Perphenazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Butyrophenones; Ketones; Phenothiazines; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Debra Bushong, MS, LPC
• Organization: UT Southwestern Medical Center

debra.bushong@utsouthwestern.edu

214-648-4653

Study Officials

• Carol A Tamminga, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 24, 2014
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 1, 2021
• Results First Posted: March 1, 2021

Record last verified: 2021-02

Locations

US (1)