We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Ketamine on Attentiveness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01165294
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : August 6, 2010
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE July 15, 2010
First Posted Date  ICMJE July 19, 2010
Last Update Posted Date August 6, 2010
Study Start Date  ICMJE October 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2010)
  • Cerebral activation of ketamine as determined by functional MRI [ Time Frame: 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 [ Time Frame: 25 and 40 minutes after end of bolus injection of ketamine/placebo ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
  • Cerebral activation of ketamine as determined by functional MRI [ Time Frame: 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 [ Time Frame: 25 and 40 minutes after end of bolus injection of ketamine/placebo ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
  • Effect of Ketamine on consciousness as measured by the "Altered States of Consciousness Rating Scale" [ Time Frame: 60 min after end of bolus injection of ketamine. ]
  • Cerebral activation induced by ketamine as measured by simultaneous fMRI / EEG under resting conditions [ Time Frame: 0 and 25 min after end of bolus injection of ketamine. ]
  • Symptom score of ketamine as measured with the Positive And Negative Symptom Scale [ Time Frame: 60 min after end of bolus injection of ketamine (= at the end of ketamine infusion). ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Ketamine on Attentiveness
Official Title  ICMJE 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)
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.
Detailed Description This will be a double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, randomized (study drug assigned by chance), 2 way crossover ketamine challenge study (participants may receive different interventions sequentially during the trial) in 24 healthy male volunteers. For all participants, this study will consist of an eligibility screening examination, two 2-day treatment periods, separated by at least 1 week, and a follow-up examination about 7 days after last dose administration. The maximal study participation for each volunteer will be around 6 weeks. Apart from observing possible neural and vascular ketamine effects, the cerebral ketamine effects will be investigated by simultaneously performing fMRI/EEG during ketamine administration. These investigations will be done while volunteers rest as well as during cognitive testing (visual oddball task). Safety evaluations include continuous monitoring of vital signs and oxygen saturation. Due to the pharmacokinetic properties of ketamine the assessments will start after an intravenous ketamine bolus (drug given directly into the vein over a short period of time) followed by a 1 minute break. During the assessments there is a continuous intravenous (minimal) drug administration. Before the assessments start there will be an intravenous bolus of 0.1 mg/kg ketamine in 5 minutes time followed by a 1 minute break after which a continuous infusion will start of 0.015625 mg/kg/min ketamine. Since the plasma level elevates during the infusion the administered dose will be lowered by 10% every 10 minutes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Placebo
    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
  • Drug: ketamine
    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.
Study Arms  ICMJE
  • Experimental: 001
    ketamine 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.
    Intervention: Drug: ketamine
  • Experimental: 002
    Placebo 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
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2010)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01165294
Other Study ID Numbers  ICMJE CR017368
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Director, Janssen Pharmaceutica N.V., Belgium
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP