Bipolar DisorderTREC-BDNCT01470781
Treatment to Enhance Cognition in Bipolar Disorder
A study testing BrainWorks in people with Bipolar Disorder and Psychosis, run by Mclean Hospital at 1 site in United States.
Trial summary
The purpose of the present study is to evaluate a neuroplasticity-oriented, computer-based cognitive remediation treatment program in patients with bipolar disorder and its effects on cognitive deficits and community functioning compared to an active, computer-based control. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bipolar Disorder, Psychosis
- What is being tested?
- BrainWorks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 1 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of BD with psychosis
- Positive and Negative syndrome Scale (PANSS) < 75; PANSS Psychosis item scores = 3 or under; Young Mania Rating Scale (YMRS) = 6 or under
- Age between 18 and 50
- Within 10 years of illness onset
- Legal and mental competency of the participant
Who cannot join
- Age under 18 or over 50
- PANSS >75; PANSS Psychosis item scores >3; YMRS > 6
- Legal or mental incompetence (legal incompetence defined by any guardianship (including of person or treatment guardianship); mental incompetence defined by failure of the informed consent survey)
- Psychiatric inpatient status at time of enrollment
- Delirium secondary to medical illness
- Psychotic or mood disorder due to general medical or neurological illness
Show all 11Show fewer
- History of head trauma
- History of seizure disorder or photo-sensitive seizures
- Use of anticholinergic medication, clozapine or olanzapine at baseline
- Rapid-cycling bipolar disorder
- Diagnosis of current substance abuse (past month) or substance dependence within the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Cognitive Remediation Treatment Program for Bipolar Disorder
The purpose of the present study is to evaluate a neuroplasticity-oriented, computer-based cognitive remediation treatment program in patients with bipolar disorder and its effects on cognitive deficits and community functioning compared to an active, computer-based control.
Read the detailed description
Cognitive dysfunction is increasingly recognized as a major feature of bipolar disorder (BD), present by illness onset, persistent into euthymia, and associated with functional outcome. Deficits are qualitatively similar to those seen in schizophrenia (SZ), and may be quantitatively similar in some patient groups, e.g. in patients with a history of psychosis. Despite strong associations between cognitive impairment and functional outcomes in BD, treatment for these symptoms at present is inadequate. Pharmacotherapies do little to address cognitive symptoms, and may even worsen them. Psychosocial cognitive remediation (CR) treatments have been developed to target these symptoms and their functional correlates, and have shown early promise in patients with SZ in improving both neurocognition and community functioning. However, despite the overlap of neurocognitive deficits between patients with SZ and BD, no studies to date have extended neuroscience-based CR to patients with BD. The present study aims to assess the efficacy of CR treatment in patients with BD with a history of psychosis using a 70-hour CR paradigm compared to a dose-matched computer-based control. It is hypothesized that patients in the CR group will exhibit improvements in cognitive and community functioning compared to controls, which will persist during a 6-month durability phase. Additionally, putative mechanisms of functional change will be examined, including mediator effects of cognitive and clinical change on community functioning. 130 patients with BD with a history of psychosis recruited from the Psychotic Disorders Programs at McLean Hospital will be randomized into either the CR or computer control group. CR will be administered using the BrainWorks program, neuroscience-based training programs that have shown early promise in patients with SZ. Participants will be assessed on measures of clinical, cognitive, and community functioning at baseline, following the 70-hour treatment or control phase, and again 6 months later. Participants may opt to participate in an functional magnetic resonance imaging (fMRI) study at pre- and post-treatment; resting state, task-based and functional connectivity, and diffusion tensor imaging data will be collected to evaluate preliminary evidence of neurobiological changes after training versus control. Additionally, participants may opt in to participation in two tasks of reward sensitivity including the Probabilistic Reward task and Richard's Delay Discounting. These tasks are administered pre- and post-treatment to evaluate the role of reward in treatment response as well as the potential for CR to modulate reward processing. This project is in keeping with the NIH's stated strategic priorities for improving mental health outcomes in patients and strengthening the impact of National Institute of Mental Health (NIMH)-supported research on public health, with specific recommendations for broad implementation of effective psychosocial interventions.
- Conditions
- Bipolar Disorder, Psychosis
- Being tested
- BrainWorks, Computer Control
- Keywords
- Bipolar Disorder, Psychosis, Cognition, Cognitive Remediation
- Medical subject headings
- Bipolar Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainWorksBehavioural
13 programs targeting cognition in 4 separate domains: Auditory processing, visual processing, social cognition, and executive functioning. Games are imbedded in a format that is engaging and interactive. Animated characters serve as "directors" for each program, explaining the tasks in both verbal and written formats and providing feedback on each trial and overall after each activity. Users move systematically through the programs and can track their progress as the go. Each session includes activities from several different games to maintain interest and train a variety of skills; however, games are presented in the order of domains listed above (i.e. auditory, then visual, then social, and finally executive) to avoid stimulus interference during the training.
Computer ControlBehavioural
Also called Sporcle
Sessions will involve generic computer games administered via the game interface "Sporcle." Sporcle is a game site that offers a collection of quiz-type activities available on line. The activities include typing, basic timed arithmetic (e.g. simple addition); picture identification (e.g. name the corporate logo; name the sitcom), and subject-based quizzes in areas like history (e.g. name the US presidents), geography (e.g. name the state capitals), and literature (e.g. book title fill-in-the-blank). An administrator can track the activity of subjects including when they logged in, which games they played and for how long, and what their accuracy was on each game. We will use a pre-developed game schedule that includes a mix of each type of game in each session, and ensures that subjects are playing the same games in the same order. This format was developed to mirror the treatment condition, as subjects are given a variety of specific games to play at each session.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation | Experimental | This arm will receive computer-based cognitive remediation treatment 3 times per week for 24 weeks, for a total of 70 hours of treatment Receives: Behavioral: BrainWorks |
| Computer Control | Placebo comparator | Group will receive 70 hours of computer time playing pre-selected computer games administered in a similar format as the Cognitive Remediation condition Receives: Behavioral: Computer Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
MATRICS Consensus Cognitive Battery (MCCB)
The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery includes 10 tasks that are designed to measure seven key cognitive domains: processing speed, attention, working memory, verbal learning, visual learning, problem solving and social cognition. These scores are also combined to yield a cognitive Composite. All subtest, domain, and composite scores are reported in standardized T scores with a mean of 50 and a standard deviation of 10; higher scores reflect better performance. For example, a score of 60 on any subtest, domain, or the Composite would represent a score 1 standard deviation above than the mean. All standardized scores are computed by the MCCB scoring software included in the testing battery, and are normed by age and sex. Total administration time is 60-90 minutes.
Measured: within 1 week prior to initiating intervention; midpoint - on average 8 weeks after initiation; post-treatment - on average 24 weeks after initiation; after 6 months no active intervention
Secondary outcomes (5)
Young Mania Rating Scale (YMRS)
The YMRS is an interview style measure asking about hallmark symptoms of mania. Total score ranges from 0 to 60 where higher scores indicate more severe symptoms of mania. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). Administration time = approximately 10 minutes
Measured: within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention
Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS is an interview-style rating scale to assess severity of symptoms of depression. The MADRS consists of 10 items scored 0-6. Total MADRS scores range from 0-60, with higher score indicates more severe depression. Typical clinical cutoff points are: 0 to 6 - normal/symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; 34 - severe depression. Administration time = 10 minutes
Measured: within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention
Positive and Negative Syndrome Scale (PANSS)
The PANSS is an interview-administered measure assessing positive and negative symptoms of psychosis, and general psychiatric symptoms. The PANSS consists of 30 total items scored 1-7 (least to most severe). Both Positive and Negative sub scales consist of 7 items each for a total possible score of 49 for each sub scale; the General sub scale consists of 16 items for a total possible score of 112. As the lowest possible score is 1, the lower bound of PANSS total score is 30. Higher scores reflect greater symptom severity. Based on the authors' original publication Kay and colleagues reported mean score in a sample of people with schizophrenia as follows:
Positive scale = 18.20 Negative scale = 21.01 General psychopathology = 37.74
Administration = approximately 40 minutes
Measured: within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention
Multnomah Community Ability Scale (MCAS)
The MCAS is an interview-based assessment that measures functioning in psychiatric patients in multiple domains including social interest and effectiveness, independence in daily living, and instrumental role functioning. The present study uses an abbreviated version of the form consisting of 11 total items scored 1-5, with higher scores reflecting better community functioning. The abbreviated version (Lewandowski et al., 2013) was selected because it assesses community functioning independent of cognition or clinical symptoms, which would represent a confound in the present study. Total possible scores range from 11-55, with higher scores reflecting better community functioning.
Measured: within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention
Social and Occupational Functioning Assessment Scale
The SOFAS is a 100-point scale similar to the Global Assessment of Functioning designed to evaluate social and occupational functioning not directly influenced by psychological symptom severity. Assessment is based on rater impression and includes a single assigned number. Scores may range from 0-100, with higher scores reflecting better functioning.
Measured: within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startJun 2011
- Primary completion1 Aug 2016
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kathryn Eve Lewandowski, Mclean Hospital
- Investigators
- Kathryn E Lewandowski, Ph.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470781
- Sponsor's protocol ID
- 1K23MH091210-01A1
- Other IDs
- K23MH091210
- Acronym
- TREC-BD
- Status last verified
- Aug 2021
- First submitted
- 11 Jul 2011
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lewandowski KE, Sperry SH, Cohen BM, Norris LA, Fitzmaurice GM, Ongur D, Keshavan MS. Treatment to Enhance Cognition in Bipolar Disorder (TREC-BD): Efficacy of a Randomized Controlled Trial of Cognitive Remediation Versus Active Control. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1242-e1249. doi: 10.4088/JCP.17m11476.
PubMed 29045770Lewandowski KE, Sperry SH, Ongur D, Cohen BM, Norris LA, Keshavan MS. Cognitive remediation versus active computer control in bipolar disorder with psychosis: study protocol for a randomized controlled trial. Trials. 2016 Mar 12;17(1):136. doi: 10.1186/s13063-016-1275-7.
PubMed 26969299
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Cognitive Remediation Treatment Program for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01470781
- Acronym / sponsor ID
- TREC-BD / 1K23MH091210-01A1
- Conditions
- Bipolar Disorder, Psychosis
- Keywords
- Bipolar Disorder, Psychosis, Cognition, Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2011
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Posted 26 Feb 2020
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 the present study is to evaluate a neuroplasticity-oriented, computer-based cognitive remediation treatment program in patients with bipolar disorder and its effects on cognitive deficits and community functioning compared to an active, computer-based control.
Detailed description
Cognitive dysfunction is increasingly recognized as a major feature of bipolar disorder (BD), present by illness onset, persistent into euthymia, and associated with functional outcome. Deficits are qualitatively similar to those seen in schizophrenia (SZ), and may be quantitatively similar in some patient groups, e.g. in patients with a history of psychosis. Despite strong associations between cognitive impairment and functional outcomes in BD, treatment for these symptoms at present is inadequate. Pharmacotherapies do little to address cognitive symptoms, and may even worsen them. Psychosocial cognitive remediation (CR) treatments have been developed to target these symptoms and their functional correlates, and have shown early promise in patients with SZ in improving both neurocognition and community functioning. However, despite the overlap of neurocognitive deficits between patients with SZ and BD, no studies to date have extended neuroscience-based CR to patients with BD. The present study aims to assess the efficacy of CR treatment in patients with BD with a history of psychosis using a 70-hour CR paradigm compared to a dose-matched computer-based control. It is hypothesized that patients in the CR group will exhibit improvements in cognitive and community functioning compared to controls, which will persist during a 6-month durability phase. Additionally, putative mechanisms of functional change will be examined, including mediator effects of cognitive and clinical change on community functioning. 130 patients with BD with a history of psychosis recruited from the Psychotic Disorders Programs at McLean Hospital will be randomized into either the CR or computer control group. CR will be administered using the BrainWorks program, neuroscience-based training programs that have shown early promise in patients with SZ. Participants will be assessed on measures of clinical, cognitive, and community functioning at baseline, following the 70-hour treatment or control phase, and again 6 months later. Participants may opt to participate in an functional magnetic resonance imaging (fMRI) study at pre- and post-treatment; resting state, task-based and functional connectivity, and diffusion tensor imaging data will be collected to evaluate preliminary evidence of neurobiological changes after training versus control. Additionally, participants may opt in to participation in two tasks of reward sensitivity including the Probabilistic Reward task and Richard's Delay Discounting. These tasks are administered pre- and post-treatment to evaluate the role of reward in treatment response as well as the potential for CR to modulate reward processing. This project is in keeping with the NIH's stated strategic priorities for improving mental health outcomes in patients and strengthening the impact of National Institute of Mental Health (NIMH)-supported research on public health, with specific recommendations for broad implementation of effective psychosocial interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation | Experimental | Behavioral: BrainWorksThis arm will receive computer-based cognitive remediation treatment 3 times per week for 24 weeks, for a total of 70 hours of treatment |
| Computer Control | Placebo comparator | Behavioral: Computer ControlGroup will receive 70 hours of computer time playing pre-selected computer games administered in a similar format as the Cognitive Remediation condition |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of BD with psychosis
- Positive and Negative syndrome Scale (PANSS) < 75; PANSS Psychosis item scores = 3 or under; Young Mania Rating Scale (YMRS) = 6 or under
- Age between 18 and 50
- Within 10 years of illness onset
- Legal and mental competency of the participant
Key exclusion criteria (11 listed)
- Age under 18 or over 50
- PANSS >75; PANSS Psychosis item scores >3; YMRS > 6
- Legal or mental incompetence (legal incompetence defined by any guardianship (including of person or treatment guardianship); mental incompetence defined by failure of the informed consent survey)
- Psychiatric inpatient status at time of enrollment
- Delirium secondary to medical illness
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 |
|---|---|---|
| BrainWorks13 programs targeting cognition in 4 separate domains: Auditory processing, visual processing, social cognition, and executive functioning. Games are imbedded in a format that is engaging and interactive. Animated characters serve as "directors" for each program, explaining the tasks in both verbal and written formats and providing feedback on each trial and overall after each activity. Users move systematically through the programs and can track their progress as the go. Each session includes activities from several different games to maintain interest and train a variety of skills; however, games are presented in the order of domains listed above (i.e. auditory, then visual, then social, and finally executive) to avoid stimulus interference during the training. | Behavioural | Cognitive Remediation |
| Computer ControlAlso: SporcleSessions will involve generic computer games administered via the game interface "Sporcle." Sporcle is a game site that offers a collection of quiz-type activities available on line. The activities include typing, basic timed arithmetic (e.g. simple addition); picture identification (e.g. name the corporate logo; name the sitcom), and subject-based quizzes in areas like history (e.g. name the US presidents), geography (e.g. name the state capitals), and literature (e.g. book title fill-in-the-blank). An administrator can track the activity of subjects including when they logged in, which games they played and for how long, and what their accuracy was on each game. We will use a pre-developed game schedule that includes a mix of each type of game in each session, and ensures that subjects are playing the same games in the same order. This format was developed to mirror the treatment condition, as subjects are given a variety of specific games to play at each session. | Behavioural | Computer Control |
Primary outcome
MATRICS Consensus Cognitive Battery (MCCB)
Time frame: within 1 week prior to initiating intervention; midpoint - on average 8 weeks after initiation; post-treatment - on average 24 weeks after initiation; after 6 months no active intervention
The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery includes 10 tasks that are designed to measure seven key cognitive domains: processing speed, attention, working memory, verbal learning, visual learning, problem solving and social cognition. These scores are also combined to yield a cognitive Composite. All subtest, domain, and composite scores are reported in standardized T scores with a mean of 50 and a standard deviation of 10; higher scores reflect better performance. For example, a score of 60 on any subtest, domain, or the Composite would represent a score 1 standard deviation above than the mean. All standardized scores are computed by the MCCB scoring software included in the testing battery, and are normed by age and sex. Total administration time is 60-90 minutes.
5 secondary outcomes
Young Mania Rating Scale (YMRS)
Time frame: within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention
Positive and Negative Syndrome Scale (PANSS)
Time frame: within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention
Multnomah Community Ability Scale (MCAS)
Time frame: within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention
Social and Occupational Functioning Assessment Scale
Time frame: within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29045770Lewandowski KE, Sperry SH, Cohen BM, Norris LA, Fitzmaurice GM, Ongur D, Keshavan MS. Treatment to Enhance Cognition in Bipolar Disorder (TREC-BD): Efficacy of a Randomized Controlled Trial of Cognitive Remediation Versus Active Control. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1242-e1249. doi: 10.4088/JCP.17m11476.
- Derived from this study: PubMed 26969299Lewandowski KE, Sperry SH, Ongur D, Cohen BM, Norris LA, Keshavan MS. Cognitive remediation versus active computer control in bipolar disorder with psychosis: study protocol for a randomized controlled trial. Trials. 2016 Mar 12;17(1):136. doi: 10.1186/s13063-016-1275-7.
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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.
Kathryn E Lewandowski, Ph.D. principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainWorks in people with Bipolar Disorder and Psychosis, run by Mclean Hospital at 1 site 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 11 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
MATRICS Consensus Cognitive Battery (MCCB) (time frame: within 1 week prior to initiating intervention; midpoint - on average 8 weeks after initiation; post-treatment - on average 24 weeks after initiation; after 6 months no active intervention). 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 NCT01470781, 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 3 Apr 2026.