A phase 3 randomised placebo- and active comparator-controlled, clinical trial to study the safety and efficacy of two doses of lurasidone HCL in acutely psychotic patients with schizophrenia
| ISRCTN | ISRCTN33909010 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33909010 |
| ClinicalTrials.gov (NCT) | NCT00615433 |
| Protocol serial number | D1050231 |
| Sponsor | Dainippon Sumitomo Pharma America Inc. (USA) |
| Funder | Dainippon Sumitomo Pharma Co., Ltd (Japan) |
- Submission date
- 26/02/2008
- Registration date
- 21/04/2008
- Last edited
- 05/08/2021
- 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
Ms Shelda Alcock
Scientific
Scientific
Dainippon Sumitomo Pharma Europe Ltd
First Floor
Southside
97-105 Victoria Street
London
SE1E 6QT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind parallel-group study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A phase 3 randomised placebo- and active comparator-controlled, clinical trial to study the safety and efficacy of two doses of lurasidone HCL in acutely psychotic patients with schizophrenia |
| Study objectives | Lurasidone HCl demonstrates greater efficiency, safety and tolerability in acutely psychotic patients with schizophrenia as compared with placebo. |
| Ethics approval(s) | Ethics approval received from: 1. Bulgaria: Multicentre trials Ethics Committee (MEC), 29/04/2008 2. Colombia: Research Ethics Committee (Comite de Etica en Investigacion Servicios Psiquiatricos S.A.), 12/02/2008 3. Lithuania: Central EC, Lithuania Bioethics Committee, 27/02/2008 4. Serbia: Ethics Committee of Clinical Centre of Serbia, 12/02/2008 Ethics approval pending from: 5. India: Ethics Committee of the Hospital for Mental Health. Expected approval date: 30/04/2008 6. Peru: Research Ethics Committee (Comite de Etica en Investigacion Hospital Nacional Guillermo Almenara). Expected approval date: 20/04/2008 7. Philippines: National Ethics Committee/National Centre for Mental Health. Expected approval date: 29/06/2008 |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | There is a 14-day screening period and a 7-day placebo washout period before randomisation of the participants for the acute phase of the trial. Acute phase: Patients will be randomly assigned to one of the four treatment arms in equal numbers: Arm 1: Lurasidone HCI 40 mg/day orally for 6 weeks Arm 2: Lurasidone HCl 120 mg/day orally for 6 weeks Arm 3: Olanzapine 15 mg (oral use film-coated tablet/capsule) for 6 weeks Arm 4: Placebo for 6 weeks Open label extension phase: All participants who complete the 6-week acute phase will be given treatment with open label lurasidone HCl (oral) for 6 months. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Lurasidone, olanzapine |
| Primary outcome measure(s) |
Change in total PANSS (the Positive And Negative Syndrome Scale) score from baseline to the end of the 6-week double-bind treatment period. |
| Key secondary outcome measure(s) |
Clinical Global Impressions - Severity (CGI-S) from baseline to the end of the double-blind treatment. |
| Completion date | 30/10/2009 |
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. Aged between 18 and 75 years of age, both genders 2. Those who provide written informed consent 3. Meets Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for a primary diagnosis of schizophrenia 4. Not pregnant; if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study 5. Able and agrees to remain off prior antipsychotic medication for the duration of study 6. Good physical health on the basis of medical history, physical examination, and laboratory screening 7. 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/alcoholism or drug abuse/dependence within the last 6 months |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 30/10/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
- Bulgaria
- Colombia
- India
- Lithuania
- Peru
- Philippines
- Serbia
Study participating centre
Dainippon Sumitomo Pharma Europe Ltd
London
SE1E 6QT
United Kingdom
SE1E 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? |
|---|---|---|---|---|---|
| Basic results | 14/02/2011 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/08/2021: Internal review.
20/07/2021: Internal review.
21/03/2016: added link to results - basic reporting.
