HealthyEarly Phase 1NCT00985933
The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers
A Early Phase 1 study testing AZD8529 in people with Healthy and Memory Impairment, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI). Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Memory Impairment
- What is being tested?
- AZD8529
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Apr 2011
- Phase
- Early 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
- Right handed
- 12th grade education or equivalent
- Able to read and write English as primary language
Who cannot join
- History of head injury
- Substance abuse or dependence
- History of claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Double-Blind, Randomized, Double Dummy, Placebo-Controlled, Three-Period Crossover Study to Assess the Effects of a mGluR2/3 Positive Allosteric Modulator [AZD8529] Upon Ketamine-Induced Cortical Stimulation and Impairment of Working-Memory Related Activation of the Prefrontal Cortex
The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI).
- Conditions
- Healthy, Memory Impairment
- Being tested
- AZD8529, Placebo to match AZD8529
- Keywords
- Healthy normal volunteers
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8529Drug
6 capsules by mouth 1 time 12 to 24 prior to assessments
Placebo to match AZD8529Drug
6 capsules by mouth 1 time 12 to 24 hours prior to assessments
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 180 mg of AZD8529 Receives: Drug: AZD8529; Drug: Placebo to match AZD8529 |
| 2 | Experimental | 50 mg AD8529 Receives: Drug: AZD8529; Drug: Placebo to match AZD8529 |
| 3 | Placebo comparator | Placebo Receives: Drug: AZD8529; Drug: Placebo to match AZD8529 |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI
Measured: 3
Ketamine Infusion
Measured: 3
Secondary outcomes (3)
Clinician Administered Dissociative States Scale (CADSS)
Positive and Negative Syndrome Scale (PANSS)
Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startFeb 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Krystal, Principal investigator, Chair, Department of PsychiatryYale University School of MedicineChief of Psychiatry, Yale-New Haven Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985933
- Sponsor's protocol ID
- D2285M00015
- Status last verified
- May 2011
- First submitted
- 25 Sep 2009
- Last updated
- 4 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Double-Blind, Randomized, Double Dummy, Placebo-Controlled, Three-Period Crossover Study to Assess the Effects of a mGluR2/3 Positive Allosteric Modulator [AZD8529] Upon Ketamine-Induced Cortical Stimulation and Impairment of Working-Memory Related Activation of the Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT00985933
- Acronym / sponsor ID
- D2285M00015
- Conditions
- Healthy, Memory Impairment
- Keywords
- Healthy normal volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 29 Sep 2009 (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 purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD8529, Drug: Placebo to match AZD8529180 mg of AZD8529 |
| 2 | Experimental | Drug: AZD8529, Drug: Placebo to match AZD852950 mg AD8529 |
| 3 | Placebo comparator | Drug: AZD8529, Drug: Placebo to match AZD8529Placebo |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Right handed
- 12th grade education or equivalent
- Able to read and write English as primary language
Key exclusion criteria (3 listed)
- History of head injury
- Substance abuse or dependence
- History of claustrophobia
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 |
|---|---|---|
| AZD85296 capsules by mouth 1 time 12 to 24 prior to assessments | Drug | 1, 2, 3 |
| Placebo to match AZD85296 capsules by mouth 1 time 12 to 24 hours prior to assessments | Drug | 1, 2, 3 |
Primary outcome
fMRI
Time frame: 3
Ketamine Infusion
Time frame: 3
3 secondary outcomes
Clinician Administered Dissociative States Scale (CADSS)
Positive and Negative Syndrome Scale (PANSS)
Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events
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 4 May 2011.
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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.
John Krystal principal investigator
Chair, Department of PsychiatryYale University School of MedicineChief of Psychiatry, Yale-New Haven Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AZD8529 in people with Healthy and Memory Impairment, run by AstraZeneca 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 3 inclusion and 3 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 4 May 2011. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
fMRI (time frame: 3). 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 4 May 2011.