DepressionPhase 4ADAPTNCT01124188
ADAPT: Addressing Depression and Pain Together
A Phase 4 study testing Higher-dose venlafaxine, Supportive management and Problem Solving Therapy for Depression and Pain in people with Depression and Back Pain, run by University of Pittsburgh at 1 site in United States.
Trial summary
The primary question addressed by this study is: Using a stepped care approach in primary care, what is the value of the combination of an antidepressant medication (Venlafaxine) and psychotherapy for seniors living with depression and chronic lower back pain when treatment with a low-dose of venlafaxine and… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Back Pain
- What is being tested?
- Higher-dose venlafaxine, Supportive management and Problem Solving Therapy for Depression and Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2016
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 or older
- Scores 10 or higher on the Patient Health Questionnaire-9 (PHQ-9). This is consistent with at least moderate depression severity.
- Endorses low back pain more days than not, of at least moderate severity, for at least the past 3 months.
- If venlafaxine up to 150 mg/day has been tried for at least 6 weeks, subjects must have been *completely* unresponsive for both depression and low back pain (based on subject report).
- During this episode of CLBP, must have tried without continued success any of the following: 1) prescription or over the counter analgesics, 2) physical therapy, 3) acupuncture, 4) injection therapy, 5) had back surgery, 6) multidisciplinary pain program, 7) psychological treatment for chronic pain such as cognitive behavioral therapy or biofeedback, or 8) any other physician-prescribed treatment for chronic low back pain.
- Upon meeting, after obtaining written informed consent, the following inclusion criteria are administered to determine protocol-eligibility:
Show all 11Show fewer
- Repeat PHQ-9 with score
- Current depression (major depression, partial remission of major depression, minor depression, or dysthymia) diagnosed with the PRIMEMD
- 20-item Numeric Rating Scale for low back pain
- The Montreal Cognitive Assessment (MoCA). Eligibility requires score of at least 24
- No history of alcohol/substance abuse or dependence for the past six months. If subjects took more analgesics than prescribed for CLBP but there was no other evidence of abuse, they will be included. Alcohol and substance abuse will be assessed with the MINI-International Neuropsychiatric Interview.
Who cannot join
- The following exclusion criteria will be assessed during telephone screening. If the individual responds in the affirmative to any of these conditions, they will not be eligible:
- Wheelchair-bound as this level of disability does not represent most older adults living with CLBP.
- Diagnosed with fibromyalgia; there is evidence that individuals with fibromyalgia may have a differential treatment response to SNRIs.
- Involved in a lawsuit related to back pain and/or receiving workers compensation.
- Subjects must also not meet any of the following exclusion criteria:
- Current or past psychotic-spectrum disorder or current or past bipolar disorder. This will be determined with the PRIME-MD and MINI-Neuropsychiatric interview.
- Medically unstable, delirious, or terminally ill; or medical contraindication to use of venlafaxine therapy, including hypersensitivity, history of venlafaxine-induced SIADH, uncontrolled narrow angle glaucoma, AST or ALT > 1.5x upper limit of normal.
- Acute low back pain "red flag" superimposed on chronic low back pain suggesting medically emergent condition (e.g., vertebral fracture, infection, cauda equina syndrome, disk herniation, cancer).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Late Life Depression Program
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Optimizing Care for Older Adults With Back Pain and Depression
The primary question addressed by this study is: Using a stepped care approach in primary care, what is the value of the combination of an antidepressant medication (Venlafaxine) and psychotherapy for seniors living with depression and chronic lower back pain when treatment with a low-dose of venlafaxine and supportive management (SM) has led to only a partial or non-response?
Read the detailed description
The primary aims of the study are:
- To test the efficacy of higher-dose Venlafaxine and Problem Solving Therapy for Depression and Pain (VEN/PST-DP) in reducing depression and pain.
- To test the efficacy of higher-dose VEN/PST-DP in reducing back-related disability and improving physical functioning.
Primary Hypotheses:
- During the 14 weeks of step 2, patients receiving VEN/PST-DP, compared to those receiving VEN/SM, will respond faster and have a higher rate of response.
- During the 14 weeks of phase 2, patients receiving VEN/PST-DP, compared to those receiving VEN/SM, will have better self-reported physical functioning. Secondary Hypothesis:
- Self-efficacy has been shown to predict treatment outcomes for both depression and pain. We have observed that the self-efficacy for pain management of these patients improves with antidepressant pharmacotherapy. We hypothesize that for subjects assigned to receive treatment with VEN/PST-DP, self-efficacy will mediate treatment response.
- Conditions
- Depression, Back Pain
- Being tested
- Higher-dose venlafaxine, Supportive management, Problem Solving Therapy for Depression and Pain
- Keywords
- Geriatric psychiatry, Aged, Elderly, Venlafaxine, Self efficacy, Pain, Psychotherapy, Effexor
- Medical subject headings
- Depression, Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher-dose venlafaxineDrug
Also called Effexor
Dosing of venlafaxine will range from 187.5-300 mg/day.
Supportive managementBehavioural
Supportive management encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.
Problem Solving Therapy for Depression and PainBehavioural
Also called PST-DP
PST-DP will be delivered over the course of 10 sessions over 14 weeks. Along with teaching the participant 7 steps of problem solving, PST-DP also includes a medication support and management component.
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention Arm | Experimental | Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP) Receives: Drug: Higher-dose venlafaxine; Behavioral: Problem Solving Therapy for Depression and Pain |
| Active Control | Active comparator | Higher-dose venlafaxine and supportive management (SM) Receives: Drug: Higher-dose venlafaxine; Behavioral: Supportive management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization
The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores < or = to 5 AND Numeric Rating Scale for pain (NRS) > or = 30% reduction from study entry.
Measured: 14 weeks
Secondary outcomes (2)
Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks
Change in RMDQ from randomization to 14 weeks. The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).
Improvement of 30% is clinically meaningful
Measured: Baseline and 14 weeks
Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks
Change in SPPB scores from randomization to 14 weeks for both arms.
The Short Physical Performance Battery (SPPB) assesses physical performance. The SPPB scores range from 0-12 and assess lower extremity strength, balance, and gait speed, three meaningful predictors of morbidity and mortality in late-life. Lower scores on the SPPB indicates greater limitations. Improvement of 0.5 points indicate clinically meaningful improvement in physical performance
Measured: Baseline and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2016
- Study completionFeb 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 (10)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan F. Karp, University of Pittsburgh
- Investigators
- Jordan F Karp, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124188
- Sponsor's protocol ID
- AG033575
- Acronym
- ADAPT
- Status last verified
- Apr 2017
- First submitted
- 13 May 2010
- Last updated
- 12 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Karp JF, Weiner DK, Dew MA, Begley A, Miller MD, Reynolds CF 3rd. Duloxetine and care management treatment of older adults with comorbid major depressive disorder and chronic low back pain: results of an open-label pilot study. Int J Geriatr Psychiatry. 2010 Jun;25(6):633-42. doi: 10.1002/gps.2386.
PubMed 19750557Karp JF, Skidmore E, Lotz M, Lenze E, Dew MA, Reynolds CF 3rd. Use of the late-life function and disability instrument to assess disability in major depression. J Am Geriatr Soc. 2009 Sep;57(9):1612-9. doi: 10.1111/j.1532-5415.2009.02398.x. Epub 2009 Jul 21.
PubMed 19682111Karp JF, Reynolds CF 3rd, Butters MA, Dew MA, Mazumdar S, Begley AE, Lenze E, Weiner DK. The relationship between pain and mental flexibility in older adult pain clinic patients. Pain Med. 2006 Sep-Oct;7(5):444-52. doi: 10.1111/j.1526-4637.2006.00212.x.
PubMed 17014605Karp JF, Weiner D, Seligman K, Butters M, Miller M, Frank E, Stack J, Mulsant BH, Pollock B, Dew MA, Kupfer DJ, Reynolds CF 3rd. Body pain and treatment response in late-life depression. Am J Geriatr Psychiatry. 2005 Mar;13(3):188-94. doi: 10.1176/appi.ajgp.13.3.188.
PubMed 15728749Arean P, Hegel M, Vannoy S, Fan MY, Unuzter J. Effectiveness of problem-solving therapy for older, primary care patients with depression: results from the IMPACT project. Gerontologist. 2008 Jun;48(3):311-23. doi: 10.1093/geront/48.3.311.
PubMed 18591356Karp JF, Shega JW, Morone NE, Weiner DK. Advances in understanding the mechanisms and management of persistent pain in older adults. Br J Anaesth. 2008 Jul;101(1):111-20. doi: 10.1093/bja/aen090. Epub 2008 May 16.
PubMed 18487247Kronenbuerger M, Magarbeh L, Kloiber S, Tavakoli E, Gorbovskaya I, Tiwari A, Kennedy JL, Karp JF, Muller DJ, Elsheikh SSM. Pharmacogenetics of venlafaxine response in older adults with depression and chronic lower back pain. Pharmacogenomics. 2026 Mar-Apr;27(3-4):77-91. doi: 10.1080/14622416.2026.2669395. Epub 2026 May 8.
PubMed 42101172Stahl ST, Jung C, Weiner DK, Pecina M, Karp JF. Opioid Exposure Negatively Affects Antidepressant Response to Venlafaxine in Older Adults with Chronic Low Back Pain and Depression. Pain Med. 2020 Aug 1;21(8):1538-1545. doi: 10.1093/pm/pnz279.
PubMed 31633789Wei W, Karim HT, Lin C, Mizuno A, Andreescu C, Karp JF, Reynolds CF 3rd, Aizenstein HJ. Trajectories in Cerebral Blood Flow Following Antidepressant Treatment in Late-Life Depression: Support for the Vascular Depression Hypothesis. J Clin Psychiatry. 2018 Oct 23;79(6):18m12106. doi: 10.4088/JCP.18m12106.
PubMed 30358242Rej S, Dew MA, Karp JF. Treating concurrent chronic low back pain and depression with low-dose venlafaxine: an initial identification of "easy-to-use" clinical predictors of early response. Pain Med. 2014 Jul;15(7):1154-62. doi: 10.1111/pme.12456. Epub 2014 Jul 4.
PubMed 25040462
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care for Older Adults With Back Pain and Depression
- ClinicalTrials.gov ID
- NCT01124188
- Acronym / sponsor ID
- ADAPT / AG033575
- Conditions
- Depression, Back Pain
- Keywords
- Geriatric psychiatry, Aged, Elderly, Venlafaxine, Self efficacy, Pain, Psychotherapy, Effexor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary question addressed by this study is: Using a stepped care approach in primary care, what is the value of the combination of an antidepressant medication (Venlafaxine) and psychotherapy for seniors living with depression and chronic lower back pain when treatment with a low-dose of venlafaxine and supportive management (SM) has led to only a partial or non-response?
Detailed description
The primary aims of the study are:
- To test the efficacy of higher-dose Venlafaxine and Problem Solving Therapy for Depression and Pain (VEN/PST-DP) in reducing depression and pain.
- To test the efficacy of higher-dose VEN/PST-DP in reducing back-related disability and improving physical functioning.
Primary Hypotheses:
- During the 14 weeks of step 2, patients receiving VEN/PST-DP, compared to those receiving VEN/SM, will respond faster and have a higher rate of response.
- During the 14 weeks of phase 2, patients receiving VEN/PST-DP, compared to those receiving VEN/SM, will have better self-reported physical functioning. Secondary Hypothesis:
- Self-efficacy has been shown to predict treatment outcomes for both depression and pain. We have observed that the self-efficacy for pain management of these patients improves with antidepressant pharmacotherapy. We hypothesize that for subjects assigned to receive treatment with VEN/PST-DP, self-efficacy will mediate treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Intervention Arm | Experimental | Drug: Higher-dose venlafaxine, Behavioral: Problem Solving Therapy for Depression and PainHigher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP) |
| Active Control | Active comparator | Drug: Higher-dose venlafaxine, Behavioral: Supportive managementHigher-dose venlafaxine and supportive management (SM) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 60 or older
- Scores 10 or higher on the Patient Health Questionnaire-9 (PHQ-9). This is consistent with at least moderate depression severity.
- Endorses low back pain more days than not, of at least moderate severity, for at least the past 3 months.
- If venlafaxine up to 150 mg/day has been tried for at least 6 weeks, subjects must have been *completely* unresponsive for both depression and low back pain (based on subject report).
- During this episode of CLBP, must have tried without continued success any of the following: 1) prescription or over the counter analgesics, 2) physical therapy, 3) acupuncture, 4) injection therapy, 5) had back surgery, 6) multidisciplinary pain program, 7) psychological treatment for chronic pain such as cognitive behavioral therapy or biofeedback, or 8) any other physician-prescribed treatment for chronic low back pain.
Key exclusion criteria (8 listed)
- The following exclusion criteria will be assessed during telephone screening. If the individual responds in the affirmative to any of these conditions, they will not be eligible:
- Wheelchair-bound as this level of disability does not represent most older adults living with CLBP.
- Diagnosed with fibromyalgia; there is evidence that individuals with fibromyalgia may have a differential treatment response to SNRIs.
- Involved in a lawsuit related to back pain and/or receiving workers compensation.
- Current or past psychotic-spectrum disorder or current or past bipolar disorder. This will be determined with the PRIME-MD and MINI-Neuropsychiatric interview.
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 |
|---|---|---|
| Higher-dose venlafaxineAlso: EffexorDosing of venlafaxine will range from 187.5-300 mg/day. | Drug | Active Control, Study Intervention Arm |
| Supportive managementSupportive management encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks. | Behavioural | Active Control |
| Problem Solving Therapy for Depression and PainAlso: PST-DPPST-DP will be delivered over the course of 10 sessions over 14 weeks. Along with teaching the participant 7 steps of problem solving, PST-DP also includes a medication support and management component. | Behavioural | Study Intervention Arm |
Primary outcome
Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization
Time frame: 14 weeks
The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores < or = to 5 AND Numeric Rating Scale for pain (NRS) > or = 30% reduction from study entry.
2 secondary outcomes
Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks
Time frame: Baseline and 14 weeks
Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks
Time frame: Baseline and 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19750557Karp JF, Weiner DK, Dew MA, Begley A, Miller MD, Reynolds CF 3rd. Duloxetine and care management treatment of older adults with comorbid major depressive disorder and chronic low back pain: results of an open-label pilot study. Int J Geriatr Psychiatry. 2010 Jun;25(6):633-42. doi: 10.1002/gps.2386.
- Background: PubMed 19682111Karp JF, Skidmore E, Lotz M, Lenze E, Dew MA, Reynolds CF 3rd. Use of the late-life function and disability instrument to assess disability in major depression. J Am Geriatr Soc. 2009 Sep;57(9):1612-9. doi: 10.1111/j.1532-5415.2009.02398.x. Epub 2009 Jul 21.
- Background: PubMed 17014605Karp JF, Reynolds CF 3rd, Butters MA, Dew MA, Mazumdar S, Begley AE, Lenze E, Weiner DK. The relationship between pain and mental flexibility in older adult pain clinic patients. Pain Med. 2006 Sep-Oct;7(5):444-52. doi: 10.1111/j.1526-4637.2006.00212.x.
- Background: PubMed 15728749Karp JF, Weiner D, Seligman K, Butters M, Miller M, Frank E, Stack J, Mulsant BH, Pollock B, Dew MA, Kupfer DJ, Reynolds CF 3rd. Body pain and treatment response in late-life depression. Am J Geriatr Psychiatry. 2005 Mar;13(3):188-94. doi: 10.1176/appi.ajgp.13.3.188.
- Background: PubMed 18591356Arean P, Hegel M, Vannoy S, Fan MY, Unuzter J. Effectiveness of problem-solving therapy for older, primary care patients with depression: results from the IMPACT project. Gerontologist. 2008 Jun;48(3):311-23. doi: 10.1093/geront/48.3.311.
- Background: PubMed 18487247Karp JF, Shega JW, Morone NE, Weiner DK. Advances in understanding the mechanisms and management of persistent pain in older adults. Br J Anaesth. 2008 Jul;101(1):111-20. doi: 10.1093/bja/aen090. Epub 2008 May 16.
- Derived from this study: PubMed 42101172Kronenbuerger M, Magarbeh L, Kloiber S, Tavakoli E, Gorbovskaya I, Tiwari A, Kennedy JL, Karp JF, Muller DJ, Elsheikh SSM. Pharmacogenetics of venlafaxine response in older adults with depression and chronic lower back pain. Pharmacogenomics. 2026 Mar-Apr;27(3-4):77-91. doi: 10.1080/14622416.2026.2669395. Epub 2026 May 8.
- Derived from this study: PubMed 31633789Stahl ST, Jung C, Weiner DK, Pecina M, Karp JF. Opioid Exposure Negatively Affects Antidepressant Response to Venlafaxine in Older Adults with Chronic Low Back Pain and Depression. Pain Med. 2020 Aug 1;21(8):1538-1545. doi: 10.1093/pm/pnz279.
- Derived from this study: PubMed 30358242Wei W, Karim HT, Lin C, Mizuno A, Andreescu C, Karp JF, Reynolds CF 3rd, Aizenstein HJ. Trajectories in Cerebral Blood Flow Following Antidepressant Treatment in Late-Life Depression: Support for the Vascular Depression Hypothesis. J Clin Psychiatry. 2018 Oct 23;79(6):18m12106. doi: 10.4088/JCP.18m12106.
- Derived from this study: PubMed 25040462Rej S, Dew MA, Karp JF. Treating concurrent chronic low back pain and depression with low-dose venlafaxine: an initial identification of "easy-to-use" clinical predictors of early response. Pain Med. 2014 Jul;15(7):1154-62. doi: 10.1111/pme.12456. Epub 2014 Jul 4.
- The Late-Life Depression Evaluation and Treatment Center provides information and treatment for depression, anxiety disorders, and insomnia in older Americans.Link provided by the sponsor.
- The University of Pittsburgh Institute on Aging provides access to a multidisciplinary network of comprehensive clinical care.Link provided by the sponsor.
- The American Association for Geriatric Psychiatry is a national association representing and serving its members and the field of geriatric psychiatry.Link provided by the sponsor.
- website describing the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jordan F Karp, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Higher-dose venlafaxine, Supportive management and Problem Solving Therapy for Depression and Pain in people with Depression and Back Pain, run by University of Pittsburgh 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 11 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 12 May 2017. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2017). 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?
Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization (time frame: 14 weeks). 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 NCT01124188, which also lists 10 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 12 May 2017.