A phase three randomised, placebo-controlled, clinical trial to study the safety and efficacy of three doses of lurasidone hydrochloride (HCl) in acutely psychotic patients with schizophrenia
| ISRCTN | ISRCTN16838597 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16838597 |
| ClinicalTrials.gov (NCT) | NCT00549718 |
| Protocol serial number | D1050229 |
| Sponsor | Dainippon Sumitomo Pharma America Inc. (USA) |
| Funder | Dainippon Sumitomo Pharma Co Ltd (Japan) |
- Submission date
- 06/02/2008
- Registration date
- 21/04/2008
- Last edited
- 22/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Shelda Alcock
Scientific
Scientific
Dainippon Sumitomo Pharma Europe Ltd (Europe)
First Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A phase three randomised, placebo-controlled, clinical trial to study the safety and efficacy of three doses of lurasidone hydrochloride (HCl) in acutely psychotic patients with schizophrenia |
| Study objectives | Lurasidone HCI demonstrates greater efficacy, safety and tolerability in acutely psychotic patients with schizophrenia as compared to placebo. |
| Ethics approval(s) | Ethics approval received from: 1. India: Ethics Committee, Seth Vadilal Sarabhai General Hospital, 04/04/2008 2. Romania: National Ethics Committee, 21/02/2008 3. Russia: Ethics Committee at the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation, 19/02/2008 4. Ukraine: Central Ethics Commission, 07/02/2008 5. France: CPP Sud Méditerranée III Ethics Committee, 16/04/2008 Ethics approval expected from: 6. Malaysia: Medical Research and Ethics Committee; submitted 27/12/2007, expected approval date: 10/03/2008 |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | Six-week, randomised, double-blind multi-centre, parallel-group study to evaluate efficacy and safety of three doses of lurasidone HCl compared with placebo (oral use film-coated tablet). After 14 day screening period and seven-day placebo washout period, patients are randomly assigned to one of four treatment arms (lurasidone HCl 40 mg/day, 80 mg/day or 120 mg/day or placebo [1:1:1 ratio]). Patients randomised to lurasidone HCl 120 mg/day will take lurasidone HCl 80 mg for days 1 - 3 then 120 mg for remainder of study. Option to continue in 22-month open-label extension phase. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Lurasidone hydrochloride (HCl) |
| Primary outcome measure(s) |
Change in total positive and negative syndrome scale (PANSS) score from baseline to the end of the double blind treatment period (six weeks). |
| Key secondary outcome measure(s) |
Clinical global impression of severity (CGI-S) from baseline to the end of the double-blind treatment (six weeks). |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 480 |
| Key inclusion criteria | 1. Provide written informed consent and aged between 18 and 75 years of age, either sex 2. Meets Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for a primary diagnosis of schizophrenia 3. Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study 4. Able and agrees to remain off prior antipsychotic medication for the duration of study 5. Good physical health on the basis of medical history, physical examination, and laboratory screening 6. Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits |
| Key exclusion criteria | 1. Considered by the investigator to be at imminent risk of suicide or injury to self, others or property 2. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia) 3. Used investigational compound within 30 days 4. Clinically significant or history of alcohol abuse/alchoholism or drug abuse/dependence within the last 6 months |
| Date of first enrolment | 01/11/2007 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
- France
- India
- Malaysia
- Romania
- Russian Federation
- Ukraine
- United States of America
Study participating centre
Dainippon Sumitomo Pharma Europe Ltd (Europe)
London
SW1E 6QT
United Kingdom
SW1E 6QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2013 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/03/2016: added link to results - basic reporting, publication reference added.
