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Effects of Ketamine and Risperidone on Cognition

NCT01140620 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2016-11-09

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

ketamine

ketamine infusion to achieve plasma concentrations of 100 ng/mL. Duration approximately 3 hours

DRUG

risperidone

risperidone (2 mg) capsule. One dosing of 2 mg.

DRUG

saline

saline infusion. Duration approximately 3 hours

DRUG

placebo risperidone

placebo capsule to match risperidone 2 mg capsule

Sponsors & Collaborators

  • Cardiff University

    collaborator OTHER

  • King's College London

    collaborator OTHER

  • P1vital Limited

    collaborator INDUSTRY

  • University of Manchester

    lead OTHER

Principal Investigators

  • Professor Bill Deakin · University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01140620 on ClinicalTrials.gov