Status:
COMPLETED
The Effect of Ketamine on Attentiveness
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
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 dru...
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 stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01165294
Start Date
October 1 2009
End Date
May 1 2010
Last Update
August 6 2010
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