High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia (HDL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01569659
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : December 9, 2015
Information provided by (Responsible Party):
Herbert Meltzer, Northwestern University

March 29, 2012
April 3, 2012
December 9, 2015
October 2011
July 2015   (Final data collection date for primary outcome measure)
Change in positive symptoms of schizophrenia [ Time Frame: Baseline to end of randomized phase (24 weeks) ]
Same as current
Complete list of historical versions of study NCT01569659 on Archive Site
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High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Lurasidone
    80 mg/day for up to 30 weeks
    Other Name: Latuda
  • Drug: Lurasidone
    Up to 240 mg/day for up to 30 weeks
    Other Name: Latuda
  • Active Comparator: Standard dose of lurasidone
    Intervention: Drug: Lurasidone
  • Experimental: High dose of lurasidone
    Intervention: Drug: Lurasidone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2015
July 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with schizophrenia or schizoaffective disorder according to DSM-IV criteria
  • All patients must be capable of giving written informed consent.
  • The criteria for treatment resistance (TR) will be those of Kane et al, (1988) which are:

    • failure to respond adequately to two or more trials with typical or atypical antipsychotic drugs, of adequate dose and duration (at least 6 weeks) lifetime and at least one such trial within the last two years. No patient with a history of a successful trial of this nature within the last two years will be eligible for inclusion. The minimum doses of antipsychotic drugs permitted in these unsuccessful trials are specified in Table 1.
    • Patients must have scores of 4 (using a 1-7 scale) or more on at least two of the following Positive and Negative Syndrome Scale (PANSS) items: delusions [P1], hallucinations [P3] or unusual thought content [G9]
    • Patients must have a total PANSS score of 70 or above
    • Patients will have had no episodes of good functioning in the previous three years (as defined by current CGI - Severity of moderate to severe, GAF below 60;
    • Personal and Social Performance Scale of 60 or below.
  • Requirement for previous exposure to antipsychotic treatment:

Patients who meet treatment resistance criteria must have had at least two trials with approved antipsychotic drugs, typical or atypical, in the standard dose range. It is recognized that some treatment resistant patients will have had good responses to antipsychotic drugs before meeting treatment resistant criteria.

  • All patients must have a Clinical Global Impression - Severity (CGI-S) scale score at screening of at least moderate severity, and must have a PSP score of 60 or below.
  • Patients may initially be inpatients or outpatients.
  • Females of child bearing potential will be admitted only if they are on stable birth control medication and understand that they should not get pregnant during the course of the study. Pregnancy tests will be done at baseline and at approximately 2 month intervals.
  • All patients must have stable housing at the current time or will be discharged to a stable outpatient setting for housing, if an inpatient.
  • Patients must be willing to remain compliant on oral medication throughout the duration of the trial.

Exclusion Criteria:

  • Patients unable to provide written, informed consent
  • Patients with a diagnosis other than schizophrenia or schizoaffective disorder.
  • Patients currently taking clozapine or have failed an adequate trial of clozapine which lasted at least 2 months.
  • Patients who have already failed trials with high doses of other atypical antipsychotic drugs such as risperidone or olanzapine..
  • Pregnant females and females who are currently breastfeeding will be excluded.
  • Patients with a diagnosis of substance dependence at screening or up to one year prior to enrollment.
  • Patients with a history of non-compliance to oral medication to a degree that would interfere with the determination of treatment resistance or diminish likelihood of complying with this protocol
  • Patients > age 60
  • Uncontrolled medical conditions or recent myocardial infarction or stroke
  • BMI =/>45
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Sunovion Pharmaceuticals
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Herbert Meltzer, Northwestern University
Northwestern University
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Northwestern University
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP