SchizophreniaPhase 2NCT01678755
A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
A Phase 2 study testing ABT-126 in people with Schizophrenia, run by AbbVie (prior sponsor, Abbott) at 20 sites in United States.
Trial summary
This is an efficacy study evaluating a 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
- Schizophrenia
- What is being tested?
- ABT-126
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 20 sitesUnited States
- Study dates
- Aug 2012to Mar 2014
- 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 a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
- Is clinically stable while receiving a regimen of one or two allowable antipsychotic medications; lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of Positive and Negative Syndrome Scale (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 contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements.
Who cannot join
- In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
- Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period.
- Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
- Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.
- Has any risk factors for Torsades de Pointes (TdP)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Site Reference ID/Investigator# 75654
Atlanta, Georgia, 30308
Site Reference ID/Investigator# 75314
Bradenton, Florida, 34201
Site Reference ID/Investigator# 72700
Cedarhurst, New York, 11516
Site Reference ID/Investigator# 72703
Chicago, Illinois, 60640
Site Reference ID/Investigator# 74436
Chino, California, 91710
Site Reference ID/Investigator# 72702
DeSoto, Texas, 75115
Site Reference ID/Investigator# 72704
Garden Grove, California, 92845
Site Reference ID/Investigator# 76534
Hoffman Estates, Illinois, 60169
Site Reference ID/Investigator# 75147
Houston, Texas, 77008
Site Reference ID/Investigator# 73984
Lake Charles, Louisiana, 70629
Site Reference ID/Investigator# 75146
Maitland, Florida, 32751
Site Reference ID/Investigator# 89553
Marlton, New Jersey, 08053
Site Reference ID/Investigator# 72699
National City, California, 91950
Site Reference ID/Investigator# 73982
New York, New York, 10065
Site Reference ID/Investigator# 73983
Oceanside, California, 92056
Site Reference ID/Investigator# 113035
Oklahoma City, Oklahoma, 73116
Site Reference ID/Investigator# 73236
Orange, California, 92868
Site Reference ID/Investigator# 86974
San Diego, California, 92102
Site Reference ID/Investigator# 73981
St Louis, Missouri, 63109
Site Reference ID/Investigator# 72701
Torrance, California, 90502
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Smokers
This is an efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
Read the detailed description
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- ABT-126, Placebo
- Keywords
- schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-126Drug
ABT-126 Low Dose
ABT-126Drug
ABT-126 High Dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ABT-126 Low Dose | Experimental | ABT-126 Low Dose Receives: Drug: ABT-126 |
| ABT-126 High Dose | Experimental | ABT-126 High Dose Receives: Drug: ABT-126 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12
Rater based interview
Measured: Change from baseline to week 12
Secondary outcomes (3)
Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)
Rater based interview
Measured: Measurements from screening period up through week 12
Symptom Severity: PANSS (Positive and Negative Syndrome Scale)
Rater based interview
Measured: Measurements from screening period up through week 12
Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
Rater based interview
Measured: Measurements from screening period up through week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionMar 2014
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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 157 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
- NCT01678755
- Sponsor's protocol ID
- M13-608
- Status last verified
- Jul 2021
- First submitted
- 31 Aug 2012
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haig GM, Wang D, Zhao J, Othman AA, Bain EE. Efficacy and Safety of the alpha7-Nicotinic Acetylcholine Receptor Agonist ABT-126 in the Treatment of Cognitive Impairment Associated With Schizophrenia: Results From a Phase 2b Randomized Controlled Study in Smokers. J Clin Psychiatry. 2018 May/Jun;79(3):16m11162. doi: 10.4088/JCP.16m11162.
PubMed 28922590Georgiades 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 7 Jul 2021. 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-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Smokers
- ClinicalTrials.gov ID
- NCT01678755
- Acronym / sponsor ID
- M13-608
- Conditions
- Schizophrenia
- Keywords
- schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Sep 2012 (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 study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.
Detailed description
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABT-126 Low Dose | Experimental | Drug: ABT-126ABT-126 Low Dose |
| ABT-126 High Dose | Experimental | Drug: ABT-126ABT-126 High Dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).
- Is clinically stable while receiving a regimen of one or two allowable antipsychotic medications; lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of Positive and Negative Syndrome Scale (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 contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements.
Key exclusion criteria (5 listed)
- In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.
- Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period.
- Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.
- Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.
- Has any risk factors for Torsades de Pointes (TdP)
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-126ABT-126 Low Dose | Drug | ABT-126 Low Dose |
| ABT-126ABT-126 High Dose | Drug | ABT-126 High Dose |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12
Time frame: Change from baseline to week 12
Rater based interview
3 secondary outcomes
Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)
Time frame: Measurements from screening period up through week 12
Symptom Severity: PANSS (Positive and Negative Syndrome Scale)
Time frame: Measurements from screening period up through week 12
Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
Time frame: Measurements from screening period up through 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 7 Jul 2021.
- Results publication: PubMed 28922590Haig GM, Wang D, Zhao J, Othman AA, Bain EE. Efficacy and Safety of the alpha7-Nicotinic Acetylcholine Receptor Agonist ABT-126 in the Treatment of Cognitive Impairment Associated With Schizophrenia: Results From a Phase 2b Randomized Controlled Study in Smokers. J Clin Psychiatry. 2018 May/Jun;79(3):16m11162. doi: 10.4088/JCP.16m11162.
- 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
20 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-126 in people with Schizophrenia, run by AbbVie (prior sponsor, Abbott) at 20 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 5 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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 (MATRICS Consensus Cognitive Battery) change from baseline to week 12 (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?
On the ClinicalTrials.gov record for NCT01678755, 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 7 Jul 2021.