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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
Study Start Date : October 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Lurasidone

Arm Intervention/treatment
Active Comparator: Standard dose of lurasidone Drug: Lurasidone
80 mg/day for up to 30 weeks
Other Name: Latuda

Experimental: High dose of lurasidone Drug: Lurasidone
Up to 240 mg/day for up to 30 weeks
Other Name: Latuda

Primary Outcome Measures :
  1. Change in positive symptoms of schizophrenia [ Time Frame: Baseline to end of randomized phase (24 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01569659

United States, Illinois
Northwestern University Department of Psychiatry and Behavioral Sciences
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University

Responsible Party: Herbert Meltzer, Professor of Psychiatry, Northwestern University Identifier: NCT01569659     History of Changes
Other Study ID Numbers: Sunovion Pharmaceuticals
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by Herbert Meltzer, Northwestern University:
Treatment resistant

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents