A clinical trial to study the effects of Lurasidone HCl in patients with acute schizophrenia

Phase 3

• Conditions: Acute schizophrenia

• Registration Number: CTRI/2009/091/000288
• Lead Sponsor: Dainippon Sumitomo Pharma America, Inc., One Bridge Plaza, Suite 510, Fort Lee, NJ 07024, USA

Brief Summary

This is a phase III, six-week, multi-center, randomized, double-blind, placebo-controlled study to examine the safety and efficacy of Lurasidone in the Acutely Psychotic Subjects with Schizophrenia. Lurasidone will be administered in tablet form, once daily by mouth in 80 and 160 mg doses. Placebo will be administered with visibly matching tablets, using the same route and regimen. Approximately 480 subjects will be randomized during the study from 70 sites all over the world. Approximately 200 subjects will be randomized during the study from 11 sites in India

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 480

Inclusion Criteria

• Main Inclusion Criteria:Subject is 18 to 75 years of age on the day of signing informed consent.Subject meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), or undifferentiated (295.90) subtypes as established by clinical interview (using the Mini-International Neuropsychiatric Interview [MINI] Plus diagnostic interview and the DSM-IV-TR as a reference).
• The duration of the subject?s illness whether treated or untreated must be greater than 1 year.Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months) and marked deterioration of function from baseline (by history) or subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening.
• Subjects who have been hospitalized for more than 2 weeks for reasons unrelated to acute exacerbation can be included with concurrence from the Medical Monitor that such hospitalization was for a reason other than acute relapse.
• For example, subjects in long-term hospitals (e.g., for years) who have a clear acute exacerbation and are transferred to an acute unit (for 2 weeks or less) are suitable for this protocol.Subject has a PANSS total score ≥80 at screening and baseline, with a score ≥4 (moderate) on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content.Subject has a score ≥4 on the CGI-S at screening and baseline.Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study.Subject has had a stable living arrangement for at least 3 months prior to randomization and agrees to return to a similar living arrangement after discharge.
• This criterion is not meant to exclude subjects who have temporarily left a stable living arrangement (e.g., due to psychosis).
• Such subjects remain eligible to participate in this protocol.
• Chronically homeless subjects should not be enrolled.
• The Medical Monitor should be consulted for individual cases as needed.

Exclusion Criteria

• Main Exclusion CriteriaSubject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.Subject has a prolactin concentration >100 ng/mL at screening or has a history of pituitary adenoma.Subject has a history of hypersensitivity to quetiapine.Subject has used quetiapine within 30 days prior to Screening and/or has a history of inadequate response or intolerability to quetiapine.Subject is resistant to neuroleptic treatment, defined as failure to respond to 2 or more marketed antipsychotic agents from 2 different classes, given at an adequate dose for at least 6 weeks.Subject has received depot neuroleptics unless the last injection was at least 1 treatment cycle before randomization.Subject has a history of treatment with clozapine for refractory psychosis and/or subject has been treated with clozapine (for any reason) within 4 months of randomization.Subject has received treatment with mood stabilizers or antidepressants within 1 week, fluoxetine hydrochloride at any time within 1 month, or a monoamine oxidase (MAO) inhibitor with 3 weeks of randomization.Subject will require treatment with any potent cytochrome P450 3A4 (CYP3A4) inhibitors or inducers during the study.
• Subject requires treatment with a drug that prolongs the QT interval corrected for individual heart rate (QTc interval).The subject demonstrates a decrease (improvement) of >20% in the PANSS score between the screening and baseline visits, or the PANSS score falls below 80 at baseline.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: Mean change from baseline in total PANSS score at endpoint (Week 6). Outcome Name: Primary Safety Endpoints: The proportion of subjects with: Adverse Events (AEs),Discontinuations due to AEs, Serious Adverse Events (SAEs)	Baseline, Week 6

Secondary Outcome Measures

Name	Time	Method
Key Secondary Efficacy Endpoints: Mean change from baseline in:CGI-S score o PANSS total score on Day 4	Day 4

Trial Locations

Locations (11)

Deenanath Mangeshkar Hospital and Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Dept. of Psychiatry, Kasturba Medical College (KMC); 🇮🇳 Bangalore, KARNATAKA, India

JSS Medical College Hospital,; 🇮🇳 Mysore, KARNATAKA, India

Justice K.S. Hegde Charitable Hospital; 🇮🇳 Nagar,-574, India

Madras Medical College & Government General Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Mahatma Gandhi Institute for Medical sciences; 🇮🇳 Wardha, MAHARASHTRA, India

SBKS Medical Institute and Research Centre; 🇮🇳 General, India

Seth V.S. General Hospital Department of Psychiatry; 🇮🇳 Ahmadabad, GUJARAT, India

Shanti Nursing Home; 🇮🇳 Kanchanwadi,Paithan, Road, India

Sri Venkateswara Medical College; 🇮🇳 India

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Deenanath Mangeshkar Hospital and Research Centre

🇮🇳Pune, MAHARASHTRA, India

Dr. Sanjay Phadke,

Principal investigator

020-40151000

sanjay_phadke@hotmail.com