SchizophreniaPhase 1NCT00986531
The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics
A Phase 1 study testing AZD8529 in people with Schizophrenia, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral probes of attention, working memory and affective reactivity in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- 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
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
Who cannot join
- ECT in the last 6 months
- 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, Placebo-Controlled, Two-Period Crossover Study to Access an Early Signal of Efficacy for Cognition and Negative Symptoms With AZD8529 in Patients With Schizophrenia
The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral probes of attention, working memory and affective reactivity in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- AZD8529, Placebo to match AZD8529
- Keywords
- schizophrenia, early phase trials
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8529Drug
2 capsules by mouth for 3 days
Placebo to match AZD8529Drug
2 capsules by mouth for 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 80 mg AZD8529 Receives: Drug: AZD8529 |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo to match AZD8529 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging (fMRI)
Measured: 1 fMRI on Day 4; 1 fMRI on Day 21
Computerized neurocognitive tests
Measured: 1 on Day -1; 1 on Day 1 and on Day 21
Secondary outcomes (4)
Positive and Negative Syndrome Scale (PANSS)
Measured: Day-1; Day 4; Day 17; Day 21
Electroencephalography (EEG)
Measured: Day 4; Day 21
Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs,
Measured: Labs at screening and on Days -1, 4, 17, 21, and 35; ECG at screening and Day 35; Physical Exam at screening and Day 35; Vital signs at screening and Days -1,4, 17, 21, and 35
Suicidality assessment, collection of adverse events
Measured: Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2011
- Study completionOct 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 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raquel Gur, Principal investigator, Hospital of the University of Pennsylvania, Dept of Psychiatry, Neuropsychiatry Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986531
- Sponsor's protocol ID
- D2285M00016
- Status last verified
- Oct 2011
- First submitted
- 29 Sep 2009
- Last updated
- 1 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period Crossover Study to Access an Early Signal of Efficacy for Cognition and Negative Symptoms With AZD8529 in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00986531
- Acronym / sponsor ID
- D2285M00016
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, early phase trials
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 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 AZD8529 improves performance on neurobehavioral probes of attention, working memory and affective reactivity in patients with schizophrenia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD852980 mg AZD8529 |
| 2 | Placebo comparator | Drug: Placebo to match AZD8529Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
Key exclusion criteria (3 listed)
- ECT in the last 6 months
- 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 |
|---|---|---|
| AZD85292 capsules by mouth for 3 days | Drug | 1 |
| Placebo to match AZD85292 capsules by mouth for 3 days | Drug | 2 |
Primary outcome
Functional magnetic resonance imaging (fMRI)
Time frame: 1 fMRI on Day 4; 1 fMRI on Day 21
Computerized neurocognitive tests
Time frame: 1 on Day -1; 1 on Day 1 and on Day 21
4 secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Time frame: Day-1; Day 4; Day 17; Day 21
Electroencephalography (EEG)
Time frame: Day 4; Day 21
Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs,
Time frame: Labs at screening and on Days -1, 4, 17, 21, and 35; ECG at screening and Day 35; Physical Exam at screening and Day 35; Vital signs at screening and Days -1,4, 17, 21, and 35
Suicidality assessment, collection of adverse events
Time frame: Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35
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 1 Nov 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.
Raquel Gur principal investigator
Hospital of the University of Pennsylvania, Dept of Psychiatry, Neuropsychiatry Section
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 AZD8529 in people with Schizophrenia, 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 1 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 1 Nov 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?
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?
Functional magnetic resonance imaging (fMRI) (time frame: 1 fMRI on Day 4; 1 fMRI on Day 21). 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 1 Nov 2011.