Schizophrenia Clinical Trial
Official title:
Effects of NMDA Receptor Antagonism on Cognitive Processes in Healthy Volunteers and Its Reversal by a Dopamine Antagonist: Comparison to Patients With Schizophrenia
The primary objective of this study is:
• To determine the effects of ketamine, which blocks the ion-channel gated by the NMDA
receptor, on performance of cognitive tasks and the extent to which these effects can be
reversed by the dopamine receptor antagonist, risperidone.
The secondary objectives of this study are:
- To establish whether patients with schizophrenia are able to reliably complete the
biomarker test battery and to assess whether their responses are similar to healthy
volunteers treated with ketamine.
- To establish a multi-site recruitment and assessment capacity based on shared Standard
Operating Procedures across three study centres.
This study is a continuation from a previous study (P1V-SCH-CT01-07). The overall aim of the
2 studies is to identify and validate potential biomarker tasks that may be used to provide
early indications into the use of new treatments for schizophrenia. The studies are
considering two potential models for schizophrenia in healthy volunteers, the first model
looks at high versus average schizotypy, schizotypy being a personality trait. The second
model, explored in this study, is a ketamine infusion.
Healthy volunteers will be identified through advertising and will initially be asked to
complete an online questionnaire.Suitability for the next stage of the study will be based
on the responses to the online questionnaire. Telephone interviews will then be conducted to
assess suitability for screening.Screening visits will then be carried out in which a full
medical and lab screening is undertaken. participants will also complete a number of
psychiatric questionnaires and interviews. If participants remain suitable they will be
invited to an assessment day in which they will be randomised to one of four study
medication arms. Participants will then complete the biomarker tasks followed by
questionnaires, rating scales and interviews. Patients with schizophrenia will form the 5th
study arm and will not receive medication. They will complete the biomarkers in the same way
as healthy volunteers.87 participants are planned, 72 healthy volunteers, 15 patients with
schizophrenia.
This study does not test any investigational medicinal product (IMP) so any ethical issues
that are associated with introducing a participant to a study drug are not applicable in
this study.
Ketamine is already a widely used anaesthetic agent but when given at sub-anaesthetic doses
is a useful tool for modelling schizophrenia psychosis.
The current study aims to assess the sensitivity of a battery of biomarker tasks (biomarkers
are measures of processes that go wrong in illnesses and that contribute to symptoms) to the
cognitive deficits induced by ketamine.
It may in future be possible to evaluate the effects of novel treatment for schizophrenia in
healthy volunteers using this model, which would then potentially provide a rapid indication
of the potential efficacy of candidate compounds at an early phase of drug development .
The study will provide information about the sensitivity of the biomarker tasks in detecting
the effects of the pharmacological treatments for schizophrenia in healthy volunteers.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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