Schizophrenia Clinical Trial
Official title:
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)
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | May 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cerebral activation of ketamine as determined by functional MRI | 25 and 40 minutes after end of bolus injection of ketamine/placebo | No | |
Primary | 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 | No | |
Secondary | Effect of Ketamine on consciousness as measured by the "Altered States of Consciousness Rating Scale" | 60 min after end of bolus injection of ketamine. | No | |
Secondary | 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. | No | |
Secondary | 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). | No |
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