Status:
COMPLETED
Effects of Ketamine and Risperidone on Cognition
Lead Sponsor:
University of Manchester
Collaborating Sponsors:
Cardiff University
King's College London
Conditions:
Healthy Volunteers
Schizophrenia
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
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 thes...
Detailed Description
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 indicatio...
Eligibility Criteria
Inclusion
- 2.1 General inclusion criteria (healthy and schizophrenia groups)
- Male or female aged 18 to 45 years
- Fluent English speakers, preferably with English as first language.
- Normotensive with sitting (5 minutes) blood pressure of 100 to 140 mmHg systolic, and 60 to 90 mmHg diastolic.
- Negative alcohol breath test.
- Negative urine drug screen.
- Participant must have consumed only their normal intake of coffee or tea on the morning of the assessment day and not consumed any other beverages containing caffeine for 2 hours prior to the assessment visit.
- Willing to follow the protocol prohibitions and restrictions .
- Participant must have signed the informed consent form.
- Those participants willing to participate in the pharmacogenomic components of the study must have signed the appropriate informed consent form.
- 2.2 Inclusion criteria applicable to healthy volunteers only
- SPQ score of 21 to 36.
- BMI of 18 to 30 kg/m².
- Non-smoker or light smoker (less than 5 cigarettes per day).
- Has not smoked in the 2 hours prior to the assessment visit.
- Females should be surgically sterile or abstinent or practising an effective method of birth control; they should have a negative urine pregnancy test.
- Healthy at screening and assessment visits as determined by the study physician, based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs, 12-lead ECG and pre-study psychological tests.
- 2.3 Inclusion criteria applicable to participants with schizophrenia only
- Documented history of a diagnosis of schizophrenia as confirmed by GP or psychiatrist or by previous research diagnostic interview.
- Confirmation of diagnosis of schizophrenia, based on the MINI structured clinical interview, carried out by the study physician.
- In good physical health at screening and assessment visits as determined by the study physician, based on a medical evaluation including medical history, physical examination, laboratory tests and vital signs1.
Exclusion
- 3.1 General exclusion criteria (healthy and schizophrenia groups)
- History of alcohol or substance dependence.
- Consumption of large amounts of caffeinated drinks.
- Have received over-the-counter medicine within 48 hours prior to assessment visit (apart from paracetamol) unless it will not interfere with the study procedures or compromise safety.
- History of, or current condition of, migraine headaches.
- Significant hearing impairment which in the opinion of the Investigator may interfere with the performance of the psychological test battery.
- Significant visual impairment or history of ocular treatment or ongoing condition which may interfere with the performance of the psychological test battery.
- Participated in a trial with any drug within 84 days of assessment visit.
- Unable or unwilling to comply with study procedures.
- 3.2 Exclusion criteria applicable to healthy volunteers only
- Known or suspected hypersensitivity or intolerance to risperidone or any of their excipients.
- Known or suspected hypersensitivity or intolerance to ketamine or any previous adverse reaction to anaesthesia.
- If female: are pregnant or are trying to get pregnant or are currently breast feeding.
- Relevant history, or presence upon clinical examination, of cardiac, ophthalmologic, gastro-intestinal, hepatic, or renal disease or other condition known to increase risk of side effects.
- History or presence of neurological or psychiatric conditions.
- Have received prescribed medication within 14 days prior to assessment visit (apart from the contraceptive pill) unless it will not interfere with the study procedures or compromise safety.
- 3.3 Exclusion criteria applicable to participants with schizophrenia only
- Changes to antipsychotic medications within 30 days of assessment visit.
- Admission to hospital, involvement with the home treatment team for psychiatric reasons or documented relapse of psychiatric symptoms within last 3 months.
- History or presence of psychiatric or neurological conditions other than schizophrenia, major depression and generalised anxiety disorder.
- Current extra-pyramidal symptoms and/or adverse effects from antipsychotic medications that, in the opinion of the study physician, will interfere with completion of the study tasks.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01140620
Start Date
June 1 2010
End Date
December 1 2010
Last Update
November 9 2016
Active Locations (3)
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1
Institute of Psychiatry, King's College London
London, Greater London, United Kingdom, SE5 8AF
2
University of Manchester (Dept of Neuropyschiatry)
Manchester, Manchester, United Kingdom, M13 9PT
3
School of Psychology, University of Cardiff
Cardiff, United Kingdom, CF10 3AT