SchizophreniaPhase 1NCT02675530
Parallel Effects of Schizophrenia and N-methyl-D-aspartate (NMDA) Antagonism
A Phase 1 study testing ketamine in people with Schizophrenia, run by Yale University at 1 site in United States.
Trial summary
This study investigates the common features of electrophysiological measures in schizophrenia and effects of NMDA antagonist ketamine in healthy volunteers. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2011
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- 21-45 years old
- Deemed healthy by the Structured Clinical Interview for DSM-NP (SCID-NP) and collateral information. Subjects will need to provide the name of a person, preferably a family member, whom the research team can contact to corroborate information.
- Male or female
- 21-45 years old
- No past or present Axis I diagnosis, as determined by the SCID-NP
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- Male or female
- 21-45 years old
- Diagnosed with DSM-IV schizophrenia based on a SCID-IP interview for patients.
- Stable dose of antipsychotic medications for at least 2 weeks prior to beginning study participation.
- Score either in the 1-3 (high functioning) range or in the 5-7 (low functioning) range of the Global Functioning Scale from the MSIF based on a screening interview.
Who cannot join
- Lifetime diagnosis of DSM-IV substance dependence (except caffeine and nicotine).
- Substance abuse, as per clinical judgment, in the past 1 year.
- Current or past DSM-IV Axis-I diagnosis.
- A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up.
- A hearing deficit greater than 30 dB in both ears detected using a Welch-Allyn audioscope (500, 1000, 2000 and 4000 Hz threshold will be evaluated) at screening.
- Major current or recent (<6 weeks) stressors.
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- History of counseling, except if counseling was for a life circumstance disorder (e.g., bereavement, divorce) or in the opinion of the investigator, is not clinically significant.
- Lifetime history of treatment with any psychotropic medications for > 1 month duration suggestive of psychiatric illness.
- Current or past Axis I diagnosis of schizophrenia or bipolar disorder in first-degree relatives.
- Any medication that could interfere with either the safety of the study and/or the outcome measures.
- Use of any illicit substances in the 4 weeks prior to beginning study participation.
- Any history indicating learning disability, mental retardation, or attention deficit disorder.
- History of head injury with loss of consciousness greater than fifteen minutes.
- Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
- Non-English speaking.
- Known sensitivity to ketamine.
- Subjects for the Schizophrenia experiment:
- Lifetime diagnosis of DSM-IV substance dependence (except caffeine and nicotine).
- Substance abuse, as per clinical judgment, in the past 1 year
- A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological.
- A hearing deficit greater than 30dB in both ears detected using a Welch-Allyn audioscope (500, 1000, 2000 and 4000 Hz threshold will be evaluated) at screening.
- Axis I diagnosis of schizophrenia or bipolar disorder in first-degree relatives.
- History of head injury with loss of consciousness greater than fifteen minutes
- Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
- Non-English speaking.
- Lifetime diagnosis of DSM-IV substance dependence (except caffeine and nicotine).
- Substance abuse, as per clinical judgment, in the past 1 year
- A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological.
- A hearing deficit greater than 30dB in both ears detected using a Welch-Allyn audioscope (500, 1000, 2000 and 4000 Hz threshold will be evaluated) at screening.
- History of head injury with loss of consciousness greater than fifteen minutes.
- Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
- Non-English speaking.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parallel Effects of Ketamine and Schizophrenia on Neurocognitive Function
This study investigates the common features of electrophysiological measures in schizophrenia and effects of NMDA antagonist ketamine in healthy volunteers.
- Conditions
- Schizophrenia
- Being tested
- ketamine
- Keywords
- NMDA, glutamate, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
For healthy volunteer arm of study, NMDA antagonist ketamine will be administered. 0.23 mg/kg over 1 minute, followed by 0.58 mg/kg/hour for 30 minutes, followed by 0.29 mg/kg/hour for 50 minutes.
No drug administration for patients with schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| healthy control | Experimental | Healthy controls will receive electrophysiological assessments before and after NMDA antagonist administration. Receives: Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
P300, an ERP measure
Measured: Baseline and repeat assessment following ketamine
Secondary outcomes (1)
(Mismatch Negativity) MMN
Measured: Baseline and repeat assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startDec 2007
- Primary completionDec 2011
- Study completionDec 2011
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Handan Gunduz-Bruce, M.D., Principal investigator, Yale Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675530
- Sponsor's protocol ID
- 0612002073
- Status last verified
- Feb 2016
- First submitted
- 17 May 2012
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Effects of Ketamine and Schizophrenia on Neurocognitive Function
- ClinicalTrials.gov ID
- NCT02675530
- Acronym / sponsor ID
- 0612002073
- Conditions
- Schizophrenia
- Keywords
- NMDA, glutamate, schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Feb 2016 (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.
This study investigates the common features of electrophysiological measures in schizophrenia and effects of NMDA antagonist ketamine in healthy volunteers.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy control | Experimental | Drug: ketamineHealthy controls will receive electrophysiological assessments before and after NMDA antagonist administration. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female
- 21-45 years old
- Deemed healthy by the Structured Clinical Interview for DSM-NP (SCID-NP) and collateral information. Subjects will need to provide the name of a person, preferably a family member, whom the research team can contact to corroborate information.
- Male or female
- 21-45 years old
Key exclusion criteria (33 listed)
- Lifetime diagnosis of DSM-IV substance dependence (except caffeine and nicotine).
- Substance abuse, as per clinical judgment, in the past 1 year.
- Current or past DSM-IV Axis-I diagnosis.
- A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up.
- A hearing deficit greater than 30 dB in both ears detected using a Welch-Allyn audioscope (500, 1000, 2000 and 4000 Hz threshold will be evaluated) at screening.
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 |
|---|---|---|
| ketamineFor healthy volunteer arm of study, NMDA antagonist ketamine will be administered. 0.23 mg/kg over 1 minute, followed by 0.58 mg/kg/hour for 30 minutes, followed by 0.29 mg/kg/hour for 50 minutes. No drug administration for patients with schizophrenia | Drug | healthy control |
Primary outcome
P300, an ERP measure
Time frame: Baseline and repeat assessment following ketamine
1 secondary outcome
(Mismatch Negativity) MMN
Time frame: Baseline and repeat assessment
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 5 Feb 2016.
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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.
Handan Gunduz-Bruce, M.D. principal investigator
Yale Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ketamine in people with Schizophrenia, run by Yale University at 1 site in United States.
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 11 inclusion and 33 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 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
P300, an ERP measure (time frame: Baseline and repeat assessment following ketamine). 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 5 Feb 2016.