SchizophreniaPhase 2NCT00921804
Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
A Phase 2 study testing AZD 8529 and Risperidone in people with Schizophrenia, run by AstraZeneca at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether treatment with daily oral dose of AZD8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- AZD 8529 and Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to May 2010
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient will need to read, understand and sign an informed consent prior to any study specific procedures
- Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry
Who cannot join
- Patients will be excluded based on recent history of significant illness or current disease as assessed by the investigator during screening process (based on physical examination, laboratory studies and electrocardiogram studies)
- Patients will be excluded if urine drug screen test show positive results
- Smoking of more than 2 packs of cigarettes a day
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Garden Grove, California
Research Site
Glendale, California
Research Site
Rockville, Maryland
About this study
Official title: A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Active-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD8529 in Adult Schizophrenia Patients
The purpose of this study is to determine whether treatment with daily oral dose of AZD8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients.
- Conditions
- Schizophrenia
- Being tested
- AZD 8529, Risperidone, Placebo to match AZD8529, Placebo to match risperidone
- Keywords
- Schizophrenia, Hallucinations, Paranoia, Inpatient schizophrenia clinical trial
- Medical subject headings
- Schizophrenia, Hallucinations, Paranoid Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD 8529Drug
40mg oral daily capsule administered as a single dose in the morning for 28 days
RisperidoneDrug
Also called Risperdal
4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days
Placebo to match AZD8529Drug
Placebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period
Placebo to match risperidoneDrug
Placebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD8529 40 mg Receives: Drug: AZD 8529; Drug: Placebo to match risperidone |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo to match AZD8529; Drug: Placebo to match risperidone |
| 3 | Other | Risperidone 4 mg (2mg on Day 1) Receives: Drug: Risperidone; Drug: Placebo to match AZD8529 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS Total Score
Measured: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Secondary outcomes (3)
PANSS Positive, Negative, and General Psychopathology Subscale Scores
Measured: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
CGI-S
Measured: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events
Measured: Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert, Litman, M.D, Principal investigator, CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850Mark Smith, Study director, AstraZeneca1800 Concord PikeWilmington, DE, 19850
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921804
- Sponsor's protocol ID
- D1960C00004
- Status last verified
- Jun 2010
- First submitted
- 12 Jun 2009
- Last updated
- 30 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Active-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD8529 in Adult Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT00921804
- Acronym / sponsor ID
- D1960C00004
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Hallucinations, Paranoia, Inpatient schizophrenia clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Jun 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 determine whether treatment with daily oral dose of AZD8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD 8529, Drug: Placebo to match risperidoneAZD8529 40 mg |
| 2 | Placebo comparator | Drug: Placebo to match AZD8529, Drug: Placebo to match risperidonePlacebo |
| 3 | Other | Drug: Risperidone, Drug: Placebo to match AZD8529Risperidone 4 mg (2mg on Day 1) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient will need to read, understand and sign an informed consent prior to any study specific procedures
- Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry
Key exclusion criteria (3 listed)
- Patients will be excluded based on recent history of significant illness or current disease as assessed by the investigator during screening process (based on physical examination, laboratory studies and electrocardiogram studies)
- Patients will be excluded if urine drug screen test show positive results
- Smoking of more than 2 packs of cigarettes a day
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 |
|---|---|---|
| AZD 852940mg oral daily capsule administered as a single dose in the morning for 28 days | Drug | 1 |
| RisperidoneAlso: Risperdal4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days | Drug | 3 |
| Placebo to match AZD8529Placebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period | Drug | 2, 3 |
| Placebo to match risperidonePlacebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period | Drug | 1, 2 |
Primary outcome
PANSS Total Score
Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
3 secondary outcomes
PANSS Positive, Negative, and General Psychopathology Subscale Scores
Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
CGI-S
Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events
Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28
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 30 Jun 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.
Robert, Litman, M.D principal investigator
CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850
Mark Smith study director
AstraZeneca1800 Concord PikeWilmington, DE, 19850
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD 8529 and Risperidone in people with Schizophrenia, run by AstraZeneca at 3 sites 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 2 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 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
PANSS Total Score (time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28). 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 30 Jun 2010.