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

This study is currently recruiting participants.
Verified February 2014 by Northwestern University
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Herbert Meltzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT01569659
First received: March 29, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Lurasidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in positive symptoms of schizophrenia [ Time Frame: Baseline to end of randomized phase (24 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569659

Contacts
Contact: D. Barrett Share, MA 312.503.0307 daniel.share1@northwestern.edu
Contact: Sara Goetzman, BA 312.503.4901 sara.goetzman@northwestern.edu

Locations
United States, Illinois
Northwestern University Department of Psychiatry and Behavioral Sciences Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Herbert Y Meltzer, MD         
Sponsors and Collaborators
Northwestern University
Sunovion
  More Information

No publications provided

Responsible Party: Herbert Meltzer, Professor of Psychiatry, Northwestern University
ClinicalTrials.gov Identifier: NCT01569659     History of Changes
Other Study ID Numbers: Sunovion Pharmaceuticals
Study First Received: March 29, 2012
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Northwestern University:
Schizophrenia
Refractory
Treatment resistant
Lurasidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014