The Effect of Ketamine on Attentiveness
Investigate the Effect of S-Ketamine, as Pharmacological Model of Schizophrenia, on the Attentiveness and Working Memory Simultaneously Measured With Functional Magnetic Resonance Imaging(fMRI)/Electroencephalogram(EEG)
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
The objective of this study is to develop an exploratory design for future Proof-of-Concept trials which reliably and accurately measure the central nervous system (CNS) effects of potentially new drugs that oppose the effects of ketamine at a subanesthetic dose level given to healthy volunteers. A functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) performed simultaneously during a ketamine challenge will register the effects triggered by Ketamine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 schizophrenia
Started Oct 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 15, 2010
CompletedFirst Posted
Study publicly available on registry
July 19, 2010
CompletedAugust 6, 2010
August 1, 2010
July 15, 2010
August 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cerebral activation of ketamine as determined by functional MRI
25 and 40 minutes after end of bolus injection of ketamine/placebo
Cerebral activation of ketamine as determined by electroencephalogram (EEG) during an oddball-task
25 and 40 minutes after end of bolus injection of ketamine/placebo
Secondary Outcomes (3)
Effect of Ketamine on consciousness as measured by the "Altered States of Consciousness Rating Scale"
60 min after end of bolus injection of ketamine.
Cerebral activation induced by ketamine as measured by simultaneous fMRI / EEG under resting conditions
0 and 25 min after end of bolus injection of ketamine.
Symptom score of ketamine as measured with the Positive And Negative Symptom Scale
60 min after end of bolus injection of ketamine (= at the end of ketamine infusion).
Study Arms (2)
001
EXPERIMENTALketamine An intravenous bolus of 0.1 mg/kg will be given in 5 minutes followed by a 1 minute break after which a continuous infusion will start at 0.015625 mg/kg/min.
002
EXPERIMENTALPlacebo An intravenous bolus will be given in 5 minutes time followed by a 1 minute break after which a continuous infusion will start. Dosage lowered every 10 minutes
Interventions
An intravenous bolus will be given in 5 minutes time followed by a 1 minute break after which a continuous infusion will start. Dosage lowered every 10 minutes
An intravenous bolus of 0.1 mg/kg will be given in 5 minutes followed by a 1 minute break after which a continuous infusion will start at 0.015625 mg/kg/min.
Eligibility Criteria
You may qualify if:
- Normal ECG and safety assessments, or minor no-relevant deviations, at screening
- Vital signs: systolic between 100 and 140 mmHg and diastolic between 50 and 90 mmHg and heart rate between 45 and 90 beats/min
- No medication intake in the last four weeks
- Volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and to adhere to the prohibitions and restrictions specified in the protocol
- Negative drug screen
You may not qualify if:
- Participation in another clinical trial in the last 3 months
- Significant allergies, allergic diathesis or known hypersensitivity for ketamine or its ingredients (ie, Benzethonium chloride)
- History of or current significant respiratory disease, cardiovascular disease, endocrinological, gastrointestinal, neurological, glaucoma and known liver and kidney failure
- Contraindications for an MRI being performed (claustrophobia, metal parts, pacemaker)
- oxygen saturation pO2 \< 90 mmHg
- Clinically significant abnormalities in ECG or laboratory values
- Recent history (within previous 6 months) of alcohol or drug abuse
- History of or current psychiatric diagnoses (DSM-IV, II) or neurological disorders
- Relatives in first or second degree with a schizophrenic disorder
- Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies
- Signs of hyperthyroidism based on the determination of T3, T4 and TSH
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 15, 2010
First Posted
July 19, 2010
Study Start
October 1, 2009
Study Completion
May 1, 2010
Last Updated
August 6, 2010
Record last verified: 2010-08