SchizophreniaPhase 1NCT01165294
The Effect of Ketamine on Attentiveness
A Phase 1 study testing ketamine in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to May 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Placebo, ketamine
- Keywords
- Ketamine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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
ketamineDrug
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 group | Role | What they receive |
|---|---|---|
| 001 | Experimental | 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. Receives: Drug: ketamine |
| 002 | Experimental | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral activation of ketamine as determined by functional MRI
Measured: 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
Measured: 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"
Measured: 60 min after end of bolus injection of ketamine.
Cerebral activation induced by ketamine as measured by simultaneous fMRI / EEG under resting conditions
Measured: 0 and 25 min after end of bolus injection of ketamine.
Symptom score of ketamine as measured with the Positive And Negative Symptom Scale
Measured: 60 min after end of bolus injection of ketamine (= at the end of ketamine infusion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startOct 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165294
- Sponsor's protocol ID
- CR017368
- Status last verified
- Aug 2010
- First submitted
- 15 Jul 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01165294
- Acronym / sponsor ID
- CR017368
- Conditions
- Schizophrenia
- Keywords
- Ketamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Study completion
- May 2010 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: ketamineketamine 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 | Experimental | Drug: PlaceboPlacebo 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAn 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 | 002 |
| ketamineAn 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. | Drug | 001 |
Primary outcome
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
3 secondary outcomes
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ketamine in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral activation of ketamine as determined by functional MRI (time frame: 25 and 40 minutes after end of bolus injection of ketamine/placebo). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2010.