High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia (NCT01569659) | Clinical Trial Compass
CompletedPhase 4
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
United States101 participantsStarted 2011-10
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual IV (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, Global Assessment of Functioning (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 …
What they're measuring
1
Change in Positive Symptoms of Schizophrenia
Timeframe: Baseline to end of randomized phase (24 weeks)