Cognitive Deficits in SchizophreniaPhase 2NCT01077700
Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia
A Phase 2 study testing ABT-288 Low Dose and ABT-288 High Dose in people with Cognitive Deficits in Schizophrenia, run by AbbVie (prior sponsor, Abbott) at 24 sites in United States.
Trial summary
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Cognitive Deficits in Schizophrenia
- What is being tested?
- ABT-288 Low Dose and ABT-288 High Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 24 sitesUnited States
- Study dates
- Mar 2010to Jul 2011
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has current DSM-IV-TR diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview.
- Is clinically stable while receiving antipsychotic therapy with one or two atypical antipsychotic medications: lack of hospitalizations from 4 months of Initial Screening Visit; taking same antipsychotic medication(s) for at least 8 weeks prior to the Day -1 visit; core positive symptoms of PANSS no worse than moderate in severity throughout Screening Period of at least 4 weeks.
- Has been diagnosed with or treated for schizophrenia for at least 2 years prior to Initial Screening Visit.
- Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to Initial Screening Visit.
- Has an identified responsible contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject and ensure compliance with protocol requirements.
Who cannot join
- Has valid current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, posttraumatic stress disorder, obsessive compulsive disorder, or a current major depressive episode.
- Has history of substance abuse (excluding nicotine or tobacco products) or alcohol abuse within 6 months prior to Screening Visit; has a substance dependence disorder (excluding nicotine or tobacco products) that has not been remitted for at least 1 year prior to Initial Screening Visit.
- Is taking any medication for extrapyramidal symptoms at any time from the Initial Screening Visit until the Day -1 Visit.
- Is taking any antidepressant that is excluded, including tricyclic antidepressants and monoamine oxidase inhibitors, at any time from 8 weeks prior to the Day -1 Visit.
- Has significant suicidal ideation at Initial Screening Visit.
- Has had a suicide attempt within 1 year prior to the Day -1 Visit.
- Has participated in another trial utilizing the MATRICS Consensus Cognitive Battery (MCCB) or UCSD Performance-Based Skills Assessment (UPSA) (any version) within 6 months prior to Initial Screening Visit.
- Is currently enrolled in any form of cognitive remediation training.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Site Reference ID/Investigator# 21662
Anaheim, California, 92804
Site Reference ID/Investigator# 21590
Austin, Texas, 78731
Site Reference ID/Investigator# 21582
Austin, Texas, 78754
Site Reference ID/Investigator# 27502
Bellevue, Washington, 98007
Site Reference ID/Investigator# 26409
Brooklyn, New York, 11235
Site Reference ID/Investigator# 21588
Cedarhurst, New York, 11516
Site Reference ID/Investigator# 26399
Charleston, South Carolina, 29407
Site Reference ID/Investigator# 21681
Chicago, Illinois, 60640
Site Reference ID/Investigator# 21589
Dayton, Ohio, 45417
Site Reference ID/Investigator# 26406
DeSoto, Texas, 75115
Site Reference ID/Investigator# 21683
Garden Grove, California, 92845
Site Reference ID/Investigator# 26402
Houston, Texas, 77008
Site Reference ID/Investigator# 21581
National City, California, 91950
Site Reference ID/Investigator# 45310
Norwalk, California, 90650
Site Reference ID/Investigator# 26407
Oklahoma City, Oklahoma, 73103
Site Reference ID/Investigator# 26400
Pasadena, California, 91106
Site Reference ID/Investigator# 21601
Philadelphia, Pennsylvania, 19131
Site Reference ID/Investigator# 21584
Pico Rivera, California, 90660
Site Reference ID/Investigator# 21761
Pittsfield, Massachusetts, 01201
Site Reference ID/Investigator# 46603
Plantation, Florida, 33317
Site Reference ID/Investigator# 45312
Riverside, California, 92506
Site Reference ID/Investigator# 45309
San Diego, California, 92128
Site Reference ID/Investigator# 26397
Shreveport, Louisiana, 71104-2136
Site Reference ID/Investigator# 21591
St Louis, Missouri, 63139
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-288 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
Read the detailed description
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-288 in approximately 210 adults with schizophrenia. Subjects will be randomized to one of three treatment groups (ABT-288 Dose 1, ABT-288 Dose 2 or placebo) for a 12-week Treatment Period. The purpose of this research study is to find out whether ABT-288 compared to placebo can improve cognition and what side effects ABT 288 may cause. Cognition is the way a person thinks, and it includes abilities like paying attention, focusing, remembering things, and solving problems. Acronyms listed in the Outcomes and/or Eligibility sections for this study are defined below:
- MCCB: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
- UPSA-2: University of California at San Diego (UCSD) Performance-Based Skills Assessment-2
- CANTAB: Cambridge Neuropsychological Test Automated Battery
- PANSS: Positive and Negative Syndrome Scale
- NSA-16: Negative Symptom Assessment-16
- CGI-S: Clinical Global Impression - Severity
- Conditions
- Cognitive Deficits in Schizophrenia
- Being tested
- ABT-288 Low Dose, Placebo, ABT-288 High Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-288 Low DoseDrug
PlaceboDrug
inactive substance
ABT-288 High DoseDrug
| Study group | Role | What they receive |
|---|---|---|
| ABT-288 Dose 1 | Experimental | low dose of ABT-288 Receives: Drug: ABT-288 Low Dose |
| ABT-288 Dose 2 | Experimental | high dose of ABT-288 Receives: Drug: ABT-288 High Dose |
| Sugar Pill | Placebo comparator | inactive substance Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition: MCCB
Measured: Measurements from screening period through 12-week treatment period
Secondary outcomes (3)
Functioning: UPSA-2
Measured: Measurements from screening period through 12-week treatment period
Cognition: CANTAB
Measured: Measurements from screening period through 12-week treatment period
Symptom Severity: PANSS, NSA-16, CGI-S
Measured: Measurements from screening period through 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive Deficits in SchizophreniaStudies of the same condition, open and under way.
- 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
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Haig, PharmD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077700
- Sponsor's protocol ID
- M10-503
- Status last verified
- Jan 2013
- First submitted
- 26 Feb 2010
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haig GM, Bain E, Robieson W, Othman AA, Baker J, Lenz RA. A randomized trial of the efficacy and safety of the H3 antagonist ABT-288 in cognitive impairment associated with schizophrenia. Schizophr Bull. 2014 Nov;40(6):1433-42. doi: 10.1093/schbul/sbt240. Epub 2014 Feb 10.
PubMed 24516190Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
PubMed 28433500
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-288 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
- ClinicalTrials.gov ID
- NCT01077700
- Acronym / sponsor ID
- M10-503
- Conditions
- Cognitive Deficits in Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Mar 2010 (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.
This is an efficacy and safety study evaluating an experimental treatment for cognitive deficits in adults with schizophrenia.
Detailed description
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-288 in approximately 210 adults with schizophrenia. Subjects will be randomized to one of three treatment groups (ABT-288 Dose 1, ABT-288 Dose 2 or placebo) for a 12-week Treatment Period. The purpose of this research study is to find out whether ABT-288 compared to placebo can improve cognition and what side effects ABT 288 may cause. Cognition is the way a person thinks, and it includes abilities like paying attention, focusing, remembering things, and solving problems. Acronyms listed in the Outcomes and/or Eligibility sections for this study are defined below:
- MCCB: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
- UPSA-2: University of California at San Diego (UCSD) Performance-Based Skills Assessment-2
- CANTAB: Cambridge Neuropsychological Test Automated Battery
- PANSS: Positive and Negative Syndrome Scale
- NSA-16: Negative Symptom Assessment-16
- CGI-S: Clinical Global Impression - Severity
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 |
|---|---|---|
| ABT-288 Dose 1 | Experimental | Drug: ABT-288 Low Doselow dose of ABT-288 |
| ABT-288 Dose 2 | Experimental | Drug: ABT-288 High Dosehigh dose of ABT-288 |
| Sugar Pill | Placebo comparator | Drug: Placeboinactive substance |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Has current DSM-IV-TR diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview.
- Is clinically stable while receiving antipsychotic therapy with one or two atypical antipsychotic medications: lack of hospitalizations from 4 months of Initial Screening Visit; taking same antipsychotic medication(s) for at least 8 weeks prior to the Day -1 visit; core positive symptoms of PANSS no worse than moderate in severity throughout Screening Period of at least 4 weeks.
- Has been diagnosed with or treated for schizophrenia for at least 2 years prior to Initial Screening Visit.
- Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to Initial Screening Visit.
- Has an identified responsible contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject and ensure compliance with protocol requirements.
Key exclusion criteria (8 listed)
- Has valid current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, posttraumatic stress disorder, obsessive compulsive disorder, or a current major depressive episode.
- Has history of substance abuse (excluding nicotine or tobacco products) or alcohol abuse within 6 months prior to Screening Visit; has a substance dependence disorder (excluding nicotine or tobacco products) that has not been remitted for at least 1 year prior to Initial Screening Visit.
- Is taking any medication for extrapyramidal symptoms at any time from the Initial Screening Visit until the Day -1 Visit.
- Is taking any antidepressant that is excluded, including tricyclic antidepressants and monoamine oxidase inhibitors, at any time from 8 weeks prior to the Day -1 Visit.
- Has significant suicidal ideation at Initial Screening Visit.
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 |
|---|---|---|
| ABT-288 Low Dose | Drug | ABT-288 Dose 1 |
| Placeboinactive substance | Drug | Sugar Pill |
| ABT-288 High Dose | Drug | ABT-288 Dose 2 |
Primary outcome
Cognition: MCCB
Time frame: Measurements from screening period through 12-week treatment period
3 secondary outcomes
Functioning: UPSA-2
Time frame: Measurements from screening period through 12-week treatment period
Cognition: CANTAB
Time frame: Measurements from screening period through 12-week treatment period
Symptom Severity: PANSS, NSA-16, CGI-S
Time frame: Measurements from screening period through 12-week treatment period
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 6 Jun 2018.
- Results publication: PubMed 24516190Haig GM, Bain E, Robieson W, Othman AA, Baker J, Lenz RA. A randomized trial of the efficacy and safety of the H3 antagonist ABT-288 in cognitive impairment associated with schizophrenia. Schizophr Bull. 2014 Nov;40(6):1433-42. doi: 10.1093/schbul/sbt240. Epub 2014 Feb 10.
- Derived from this study: PubMed 28433500Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
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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.
George Haig, PharmD study director
AbbVie
24 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 ABT-288 Low Dose and ABT-288 High Dose in people with Cognitive Deficits in Schizophrenia, run by AbbVie (prior sponsor, Abbott) at 24 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 5 inclusion and 8 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
Cognition: MCCB (time frame: Measurements from screening period through 12-week treatment period). 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 NCT01077700, which also lists 2 linked publications.
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 6 Jun 2018.