SchizophreniaPhase 2HALONCT00528905
Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia
A Phase 2 study testing AZD3480 in people with Schizophrenia, run by AstraZeneca at 80 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal dose(s) to be used in future trials. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- AZD3480
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 80 sitesin 2 countries
- Study dates
- Aug 2007to Nov 2008
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia
- Outpatient at the time of screening and randomization
- Stable housing defined as having a place to live in the community (ie, not in a hospital or nursing home)
- Active cigarette smoking (10 or more cigarettes per day
Who cannot join
- Any significant psychiatric or neurological disease other than schizophrenia, or current diagnosis of major depressive disorder
- Known or suspected drug or alcohol abuse within the 6 months or urine toxicology test positive for illegal or non-prescribed substances
- Impaired vision and/or hearing making cognitive testing difficult
Trial locations and contacts
80 sites in 2 countries.
80 sites in 2 countries
United States66 sites
Research Site
Allentown, Pennsylvania
Research Site
Anaheim, California
Research Site
Atlanta, Georgia
Research Site
Augusta, Georgia
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Austin, Texas
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Boca Raton, Florida
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Brooklyn, New York
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Cedarhurst, New York
Research Site
Cerritos, California
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Charleston, South Carolina
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Cherry Hill, New Jersey
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Chicago, Illinois
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Cincinnati, Ohio
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Clementon, New Jersey
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Columbus, Ohio
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Coral Gables, Florida
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Costa Mesa, California
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DeSoto, Texas
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DuBois, Pennsylvania
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East Orange, New Jersey
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Elmsford, New York
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Escondido, California
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Garden Grove, California
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Glen Burnie, Maryland
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Glen Oaks, New York
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Haverhill, Massachusetts
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Houston, Texas
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Indianapolis, Indiana
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Irving, Texas
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Jamaica, New York
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Joliet, Illinois
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Kettering, Ohio
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Las Vegas, Nevada
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Little Rock, Arkansas
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Long Beach, California
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Los Angeles, California
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Marietta, Georgia
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Memphis, Tennessee
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Minneapolis, Minnesota
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Nashua, New Hampshire
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New Britain, Connecticut
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New Haven, Connecticut
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New Orleans, Louisiana
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New York, New York
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Newark, New Jersey
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Norristown, Pennsylvania
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North Miami, Florida
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Oceanside, California
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Oklahoma City, Oklahoma
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Orlando, Florida
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Paramus, New Jersey
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Pasadena, California
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Philadelphia, Pennsylvania
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Pico Rivera, California
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Pittsfield, Massachusetts
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Richmond, Virginia
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Rochester, New York
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San Antonio, Texas
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San Diego, California
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Santa Ana, California
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Schaumburg, Illinois
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Spokane, Washington
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St Louis, Missouri
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Staten Island, New York
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Tampa, Florida
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Washington D.C., District of Columbia
Canada14 sites
Research Site
Burlington, Ontario
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Calgary, Alberta
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Greater Sudbury, Ontario
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Halifax, Nova Scotia
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Mississauga, Ontario
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Montreal, Quebec
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Orléans, Ontario
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Penticton, British Columbia
Research Site
Red Deer, Alberta
Research Site
Sydney, Nova Scotia
Research Site
Toronto, Ontario
Research Site
Victoria, British Columbia
Research Site
Windsor, Ontario
Research Site
Winnipeg, Manitoba
About this study
Official title: A Multi-Center Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase IIb Proof of Concept Study With 3 Oral Groups of AZD3480 During 12 Weeks Treatment of Cognitive Deficits in Patients With Schizophrenia
The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal dose(s) to be used in future trials.
- Conditions
- Schizophrenia
- Being tested
- AZD3480
- Keywords
- Schizophrenia, Cognitive Deficits
- Medical subject headings
- Schizophrenia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3480Drug
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: AZD3480 |
| 2 | Experimental | AZD3480 oral Receives: Drug: AZD3480 |
| 3 | Experimental | AZD3480 oral dose Receives: Drug: AZD3480 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Domain scores for Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Verbal Fluency as measured on the IntegNeuro computerized test battery of cognitive function
Measured: Change from baseline to Week 12
Secondary outcomes (1)
UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS)
Measured: Change from baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2008
- Study completionNov 2008
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Larry Rodichok, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528905
- Sponsor's protocol ID
- D3690C00011
- Acronym
- HALO
- Status last verified
- Nov 2008
- First submitted
- 10 Sep 2007
- Last updated
- 25 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase IIb Proof of Concept Study With 3 Oral Groups of AZD3480 During 12 Weeks Treatment of Cognitive Deficits in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00528905
- Acronym / sponsor ID
- HALO / D3690C00011
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cognitive Deficits
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Sep 2007 (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 demonstrate that AZD3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal dose(s) to be used in future trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: AZD3480Placebo |
| 2 | Experimental | Drug: AZD3480AZD3480 oral |
| 3 | Experimental | Drug: AZD3480AZD3480 oral dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia
- Outpatient at the time of screening and randomization
- Stable housing defined as having a place to live in the community (ie, not in a hospital or nursing home)
- Active cigarette smoking (10 or more cigarettes per day
Key exclusion criteria (3 listed)
- Any significant psychiatric or neurological disease other than schizophrenia, or current diagnosis of major depressive disorder
- Known or suspected drug or alcohol abuse within the 6 months or urine toxicology test positive for illegal or non-prescribed substances
- Impaired vision and/or hearing making cognitive testing difficult
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 |
|---|---|---|
| AZD3480oral capsule | Drug | 1, 2, 3 |
Primary outcome
Domain scores for Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Verbal Fluency as measured on the IntegNeuro computerized test battery of cognitive function
Time frame: Change from baseline to Week 12
1 secondary outcome
UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS)
Time frame: Change from baseline to Week 12
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 25 Nov 2008.
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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.
Larry Rodichok, MD study director
AstraZeneca
80 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD3480 in people with Schizophrenia, run by AstraZeneca at 80 sites in 2 countries.
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 4 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 25 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Canada. 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?
Domain scores for Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Verbal Fluency as measured on the IntegNeuro computerized test battery of cognitive function (time frame: Change from baseline to Week 12). 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 25 Nov 2008.