HDL: High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT01569659

Collaborator

Sunovion (Industry)

101

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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 Drug: Lurasidone	Phase 4

Study Design

Study Type:

Interventional

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 :

Oct 1, 2011

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard dose of lurasidone	Drug: Lurasidone 80 mg/day for up to 30 weeks Other Names: Latuda
Experimental: High dose of lurasidone	Drug: Lurasidone Up to 240 mg/day for up to 30 weeks Other Names: Latuda

Arm

Intervention/Treatment

Active Comparator: Standard dose of lurasidone

Drug: Lurasidone

80 mg/day for up to 30 weeks

Other Names:

Latuda

Experimental: High dose of lurasidone

Drug: Lurasidone

Up to 240 mg/day for up to 30 weeks

Other Names:

Latuda

Outcome Measures

Primary Outcome Measures

Change in positive symptoms of schizophrenia [Baseline to end of randomized phase (24 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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