Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-01 @ 2:02 PM
Study NCT ID:
NCT01569659
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2012-03-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HDL
Brief Summary:
The aim of this study is to compare the efficacy of a flexible high dose of lurasidone to a standard dose of lurasidone in patients with treatment resistant schizophrenia or schizoaffective disorder. Efficacy of both dosage groups will be measured through testing of positive symptoms and other components of psychopathology (negative symptoms, general psychopathology, anxiety, depression, cognitive function, global function, severity of illness and tolerability). Patients must qualify for treatment resistance after two or more antipsychotic drug trials to be included in this trial.
Detailed Description:
The purpose of this study is to conduct a double-blind, randomized trial of lurasidone (80 mg vs 160-240 mg/day) after a 6 week trial of 80 mg/day (phase 1), in treatment resistant adult patients. Only those patients who still have persistent moderate to severe positive symptoms, even if they have shown some improvement at 80 mg/day will proceed to phase II (randomization). In phase II, 30 subjects will be randomized to continue 80 mg lurasidone and 40 will initiate a titration schedule, beginning at 120 mg at week 7. The high-dose group will be increased an additional 40 mg/day every week, thereafter, to a total of 240 mg/day, if adequately tolerated, which would include a worsening of psychopathology as assessed by the PANSS or CGI-S. The dose will remain at 240/day, or the highest dose tolerated, for a duration of 6 months from the time the 120 mg/day dose was initiated. No additional antipsychotic drug of any kind will be permitted in either group during Phase II. Because they are treatment resistant, patients who are doing poorly in either of the two groups in phase II as indicated by level of psychopathology, or as tolerated, and who the clinicians at any site feel should no longer receive lurasidone, will be dropped, and would ordinarily be considered for treatment with clozapine. Where possible, another assessment of these patients, two weeks and four weeks after completion of the trial or early termination will be conducted.
All subjects who enter the phase 1 study will be consented to obtain a blood sample for genetic studies to search for possible markers for response to lurasidone and treatment resistant schizophrenia. DNA from non-treatment resistant patients already studied by the PI will be available for comparison. Following the completion of the study, the PI and the sponsor will discuss how best to analyze the DNA obtained and a separate contract will be written, if indicated.
All subjects who enter the phase 1 study will be consented to obtain a blood sample for genetic studies to search for possible markers for response to lurasidone and treatment resistant schizophrenia. DNA from non-treatment resistant patients already studied by the PI will be available for comparison. Following the completion of the study, the PI and the sponsor will discuss how best to analyze the DNA obtained and a separate contract will be written, if indicated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: