IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2 (SINAPPS2)
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|ClinicalTrials.gov Identifier: NCT03194815|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : February 19, 2018
A randomised phase II double-blinded placebo-controlled trial designed to explore the utility of immunotherapy for patients with acute psychosis associated with anti-neuronal membranes (NMDA-receptor or Voltage Gated Potassium Channel).
Primary objective: To test the efficacy of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes.
Secondary objective: To test safety of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes.
|Condition or disease||Intervention/treatment||Phase|
|Psychosis Autoimmune Encephalitis||Drug: Intravenous immunoglobulin Drug: Placebo Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised Phase II Double-blinded Placebo-controlled Trial of Intravenous Immunoglobulins and Rituximab in Patients With Antibody-associated Psychosis (SINAPPS2)|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Intravenous immunoglobulin and Rituximab
One cycle of intravenous immunoglobulin (IVIG) 2g/kg over 2-5 days (days 1-5) followed by (b) two infusions of 1g rituximab (the first infusion starting between days 28-35, and the second infusion 14 days later), each with 100mg methylprednisolone.
Drug: Intravenous immunoglobulin
This is a blood product containing antibodies from thousands of healthy donors.
Rituximab is a type of biological therapy. It removes B-cells and helps to reduce the inflammation
Other Name: MabThera
Placebo Comparator: Placebo
One cycle of 0.9% saline solution over 2-5 days (days 1-5) followed by (b) two infusions of placebo solution alongside placebo pill - in equal volumes to steroid pre-medication and rituximab.
This is the control, or sham, treatment
Other Name: Saline solution
- Time to start of remission [ Time Frame: up to 18 months ]remission defined as Positive and Negative Syndrome Scale (PANSS) score 3 or less on PANSS items P1, P2, P3, N1, N4, N6, G5 and G9 sustained for 6 months
- Time to first treatment response (whether sustained or not) [ Time Frame: up to 18 months ]Treatment response defined as score of 3 or less on each of the following PANSS items: P1, P2, P3, N1, N4, N6, G5, and G9.
- Relapse rate [ Time Frame: 18 months ]Relapse rate is defined as a score 4 or more on PANSS items P1, P2, P3, N1, N4, N6, G5, and G9.
- Number of adverse effects [ Time Frame: 18 months ]total number of patient reported adverse effects
- Proportion of patients reaching 20% reduction in PANSS total score [ Time Frame: 12 months ]20% reduction in the PANSS total score (all PANNS items included)
- Proportion of patients reaching 30% reduction in PANSS total score [ Time Frame: 12 months ]30% reduction in the PANSS total score (all PANNS items included)
- Proportion of patients reaching 40% reduction in PANSS total score [ Time Frame: 12 months ]40% reduction in the PANSS total score (all PANNS items included)
- Changes in the Clinical Global Impression Scale in Schizophrenia (CGI-Schizophrenia) [ Time Frame: 12 months ]Change in CGI-Schizophrenia scores from baseline to month 12
- Changes in the Young Mania Rating Scale (YMRS) [ Time Frame: 12 months ]Change in YMRS total score from baseline to month 12
- Changes in the Antipsychotic Non-Neurological Side-Effects Rating Scale (ANNSERS) [ Time Frame: 12 months ]Change in ANNSERS total score from baseline to month 12
- Changes in the Brief Assessment of Cognition in Schizophrenia (BACS) [ Time Frame: 12 months ]Change in BACS scores from baseline to month 12
- Changes in the Global Assessment of Functioning scale (GAF) [ Time Frame: 12 months ]Change in the GAF score from baseline to month 12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194815
|Contact: Alastdair Coles, PhD FRCP||+44 (0)1223 firstname.lastname@example.org|
|Contact: Belinda Lennox, DM MRCPsych||: +44(0)1865 email@example.com|
|Cambridge University Hospitals||Recruiting|
|Cambridge, United Kingdom|
|Contact: Alasdair Coles, PhD FRCP +44 (0)1223 762016 firstname.lastname@example.org|
|University College London Hospitals Nhs Foundation Trust||Recruiting|
|London, United Kingdom, NW1 2PG|
|Contact: Michael Zandi, PhD MRCP email@example.com|
|Oxford Radcliffe Hospitals||Recruiting|
|Oxford, United Kingdom|
|Contact: Belinda Lennox, DM MRCPsych : +44(0)1865 613145 firstname.lastname@example.org|
|Principal Investigator:||Alasdair Coles, PhD FRCP||University of Cambridge, UK|