SchizophreniaPhase 1/2NCT00825539
Pharmacodynamic/Pharmacokinetic Study of AQW051 in Schizophrenia
A Phase 1/2 study testing AQW051 in people with Schizophrenia, run by Novartis Pharmaceuticals at 7 sites in United States.
Trial summary
Part 1 of the study will assess the enhancement of task-related brain activation (BOLD response) in key brain areas in schizophrenia during the performance of working memory, episodic memory and visual activation tasks as measured by functional magnetic resonance imaging (fMRI) in people with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- AQW051
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2009to Nov 2011
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV/DSM IV TR)
- Subjects will be currently treated with the stable regimen of one or more of the following second generation antipsychotics: olanzapine, risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
- Subjects will meet the following symptom criteria:
- Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior or Unusual Thought Content item scores less than or equal to 5
- BPRS Conceptual Disorganization item score less than or equal to 4
- Simpson-Angus Scale (SAS) total score less than or equal to 6
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- Calgary Depression Scale (CDS) total score less than or equal to 10
- Subjects will meet the following cognitive performance criteria:
- Maximum performance level: Performance below 1.0 SD from perfect performance on the Hopkins Verbal Learning Test (HVLT) total (31 or less),
- Minimum performance level: subject must be able to validly complete the fMRI cognitive paradigms
- WTAR: 5th grade reading level assessment
- Subjects must be symptomatically stable and not suffer from an acute exacerbation of their psychosis
- Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion. Pregnancy tests are required of all female subjects regardless of reported sterilization.
- When performed at screening and practice visit, the result of this test must be received before the subject may be dosed.
- Male subjects must be using two acceptable methods of contraception, (e.g., spermicidal gel plus condom) for the entire duration of the studyuntil the Study Completion visit.
- Subject must have sufficiently stable overall health, as determined by the Investigator. The regular intake of concomitant drugs will be allowed, if the patient is on stable treatment for at least 3 months prior to study enrollment and the concomitant drug does not belong to the list of medication that are not allowed according to Appendix 3. If the patient takes more than one concomitant medication, it is at the Investigator's discretion to decide about the patient's eligibility, depending on the nature of the concomitant medications and the patient's overall health.
Who cannot join
- Current treatment with conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine
- Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system
- Subjects with a DSM-IV diagnosis of substance abuse (other than nicotine) within the last month.
- Subjects with a history of significant head injury/trauma, as defined by:
- Loss of consciousness (LOC) for more than 1 hour
- Recurring seizures resulting from the head injury
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- Clear cognitive sequelae of the injury
- Cognitive rehabilitation following the injury
- Subjects with a medical or neurological disorder or treatment for such disorder that could interfere with the study medication of the assessment of the subject
- Use of certain concomitant medication
- No grapefruit or grapefruit juice is to be consumed for 14 days prior to dosing until 7 days following the last dose.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Maryland Psychiatric Research Centre, Spring Grove Hospital Grounds
Baltimore, Maryland, 21228
Massachusetts General Hospital (Freedom Trail Clinic)
Boston, Massachusetts, 02115
JUH Clinical Research (Duke University),
Butner, North Carolina, 27509
Department of Psychiatry & Behavioural Sciences, Feinberg School of Medicine (Northwestern University)
Chicago, Illinois, 60611
West LA VA Healthcare Center (UCLA)
Los Angeles, California, 90073
Columbia University
New York, New York, 10032
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Single-dose, Placebo-controlled, Stratified, Randomized, Double-blind, Crossover to Study Pharmacodynamic Effects of AQW051 Followed by a 4-week Multiple-dose Safety and Tolerability in People With Chronic Stable Schizophrenia.
Part 1 of the study will assess the enhancement of task-related brain activation (BOLD response) in key brain areas in schizophrenia during the performance of working memory, episodic memory and visual activation tasks as measured by functional magnetic resonance imaging (fMRI) in people with schizophrenia. Part 2 of the study will assess the safety and tolerability of multiple doses of AQW051 in people with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- AQW051, Placebo
- Keywords
- Schizophrenia, Manic depression, anxiety
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQW051Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| AQW051 | Experimental | Not described Receives: Drug: AQW051 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Assess BOLD response in key brain areas in schizophrenia patients during the performance of tasks as measured by (fMRI) in people with schizophrenia.
Measured: 2 years (Part 1: 1 year)
Part 2: Assess safety and tolerability of multiple doses of AQW051 schizophrenia patients.
Measured: Part 2: 8 months
Secondary outcomes (4)
Measure: To assess the effects of a single dose of AQW051 on performance of working and episodic memory tasks in people with schizophrenia. (Part 1)
Measured: Time Frame: 2 years (Part 1: 1 year; Part 2: 8 months)
Measure: To determine the relationship of exposure to brain activation after a single dose of AQW051 in people with schizophrenia. (Part 1)
Measured: 2 years (Part 1: 1 year; Part 2: 8 months)
Measure: To determine the dose-exposure response relationship of multiple doses of AQW051 in people with schizophrenia. (Part 2)
Measured: 2 years (Part 1: 1 year; Part 2: 8 months)
Measure: To explore effects of multiple doses of AQW051 on measures of cognition in people with schizophrenia. (Part 2)
Measured: 2 years (Part 1: 1 year; Part 2: 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825539
- Sponsor's protocol ID
- CAQW051A2202
- Status last verified
- Feb 2013
- First submitted
- 19 Jan 2009
- Last updated
- 24 Dec 2020
- Results posted
- No
Publications
Barch DM, Marder SR, Harms MP, Jarskog LF, Buchanan RW, Cronenwett W, Chen LS, Weiss M, Maguire RP, Pezous N, Feuerbach D, Lopez-Lopez C, Johns DR, Behrje RB, Gomez-Mancilla B. Task-related fMRI responses to a nicotinic acetylcholine receptor partial agonist in schizophrenia: A randomized trial. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Nov 3;71:66-75. doi: 10.1016/j.pnpbp.2016.06.013. Epub 2016 Jun 28.
PubMed 27371157
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Placebo-controlled, Stratified, Randomized, Double-blind, Crossover to Study Pharmacodynamic Effects of AQW051 Followed by a 4-week Multiple-dose Safety and Tolerability in People With Chronic Stable Schizophrenia.
- ClinicalTrials.gov ID
- NCT00825539
- Acronym / sponsor ID
- CAQW051A2202
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Manic depression, anxiety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 21 Jan 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.
Part 1 of the study will assess the enhancement of task-related brain activation (BOLD response) in key brain areas in schizophrenia during the performance of working memory, episodic memory and visual activation tasks as measured by functional magnetic resonance imaging (fMRI) in people with schizophrenia. Part 2 of the study will assess the safety and tolerability of multiple doses of AQW051 in people with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| AQW051 | Experimental | Drug: AQW051 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV/DSM IV TR)
- Subjects will be currently treated with the stable regimen of one or more of the following second generation antipsychotics: olanzapine, risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
- Subjects will meet the following symptom criteria:
- Subjects will meet the following cognitive performance criteria:
- Subjects must be symptomatically stable and not suffer from an acute exacerbation of their psychosis
Key exclusion criteria (12 listed)
- Current treatment with conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine
- Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system
- Subjects with a DSM-IV diagnosis of substance abuse (other than nicotine) within the last month.
- Subjects with a history of significant head injury/trauma, as defined by:
- Subjects with a medical or neurological disorder or treatment for such disorder that could interfere with the study medication of the assessment of the subject
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 |
|---|---|---|
| AQW051 | Drug | AQW051 |
| Placebo | Drug | Placebo |
Primary outcome
Part 1: Assess BOLD response in key brain areas in schizophrenia patients during the performance of tasks as measured by (fMRI) in people with schizophrenia.
Time frame: 2 years (Part 1: 1 year)
Part 2: Assess safety and tolerability of multiple doses of AQW051 schizophrenia patients.
Time frame: Part 2: 8 months
4 secondary outcomes
Measure: To assess the effects of a single dose of AQW051 on performance of working and episodic memory tasks in people with schizophrenia. (Part 1)
Time frame: Time Frame: 2 years (Part 1: 1 year; Part 2: 8 months)
Measure: To determine the relationship of exposure to brain activation after a single dose of AQW051 in people with schizophrenia. (Part 1)
Time frame: 2 years (Part 1: 1 year; Part 2: 8 months)
Measure: To determine the dose-exposure response relationship of multiple doses of AQW051 in people with schizophrenia. (Part 2)
Time frame: 2 years (Part 1: 1 year; Part 2: 8 months)
Measure: To explore effects of multiple doses of AQW051 on measures of cognition in people with schizophrenia. (Part 2)
Time frame: 2 years (Part 1: 1 year; Part 2: 8 months)
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 24 Dec 2020.
- Derived from this study: PubMed 27371157Barch DM, Marder SR, Harms MP, Jarskog LF, Buchanan RW, Cronenwett W, Chen LS, Weiss M, Maguire RP, Pezous N, Feuerbach D, Lopez-Lopez C, Johns DR, Behrje RB, Gomez-Mancilla B. Task-related fMRI responses to a nicotinic acetylcholine receptor partial agonist in schizophrenia: A randomized trial. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Nov 3;71:66-75. doi: 10.1016/j.pnpbp.2016.06.013. Epub 2016 Jun 28.
- Results for CAQW051A2202 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AQW051 in people with Schizophrenia, run by Novartis Pharmaceuticals at 7 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 16 inclusion and 12 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 combined 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.
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?
Part 1: Assess BOLD response in key brain areas in schizophrenia patients during the performance of tasks as measured by (fMRI) in people with schizophrenia. (time frame: 2 years (Part 1: 1 year)). 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?
On the ClinicalTrials.gov record for NCT00825539, which also lists 1 linked publication.
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 24 Dec 2020.