SchizophreniaPhase 2NCT02462473
A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry
A Phase 2 study testing Aripiprazole, Olanzapine and Paliperidone in people with Schizophrenia and Schizoaffective Disorder, run by Janssen Research & Development, LLC at 3 sites in United States.
Trial summary
The purpose of this study is to determine the number of Medication Treatment Modifications (MTMs) made by the clinician at every visit when antipsychotic medication plasma levels (AMPL) results are available compared to when AMPL results are not available. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Aripiprazole, Olanzapine and Paliperidone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2015to Jan 2016
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has a diagnosis of schizophrenia (Code 295.90) or schizoaffective disorder (Code 295.70) according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM 5), based on history and clinical assessment by the investigator
- Participant has current active medication management issues and has experienced a medication treatment modification within the 6 weeks prior to Screening
- Participant is currently taking one or more of the following antipsychotic medications for at least 1 week for oral antipsychotics and at least 1 injection cycle for long-acting injectable (LAI) antipsychotics. In addition, the treating clinician plans to continue the antipsychotic medication(s) for at least 4 weeks subsequent to the Screening visit. Participant may be taking more than one formulation of a particular medication (such as oral and LAI) at or above the minimum dose specified in protocol. Qualifying formulations of the antipsychotic medications are: Aripiprazole (oral formulation only), Olanzapine (oral formulation only), Paliperidone (oral and/or LAI formulations), Quetiapine (oral formulation only), and Risperidone (oral and/or LAI formulations)
- Participant has had no clinically significant suicidal behavior or ideation during the week prior to Screening, according to the investigator's judgment
- Participant is generally healthy and has no clinically significant or unstable medical problems as determined by the investigator, except for the indication for which the antipsychotic treatment is being prescribed. This determination must be recorded in the participant's source documents and initialed by the investigator
Who cannot join
- Participant has been attending the outpatient psychiatric clinic for more than 12 months since the last psychiatric hospitalization
- During Screening, participant has active alcohol or substance use disorder (except tobacco) of moderate or severe severity according to DSM 5 criteria
- Participant has a history of or currently has a clinically significant (particularly unstable) medical illness, other than the indication for which the participant is taking antipsychotic therapy, that the investigator considers should exclude the participant or that could interfere with the participant completing the study or with interpretation of the study results. Treated, stable, chronic medical problems are allowed, as long as these conditions do not interfere with the study assessments
- Participant is receiving clozapine
- Participant has donated blood or blood products or had substantial loss of blood (ie, blood loss of approximately more than 450 milliliter (mL) or blood loss that required a blood transfusion) within 1 month of Screening or has the intention to donate blood or blood products during the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Conshohocken, Pennsylvania
Study site
Kissimmee, Florida
Study site
Torrance, California
About this study
Official title: A Sequential and Parallel Cohort Design to Test the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry
The purpose of this study is to determine the number of Medication Treatment Modifications (MTMs) made by the clinician at every visit when antipsychotic medication plasma levels (AMPL) results are available compared to when AMPL results are not available.
Read the detailed description
This is a naturalistic, open-label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study), pilot clinical utility study with a sequential and parallel cohort design in participants with a diagnosis of schizophrenia or schizoaffective disorder. The study consists of up to 3 Phases: Screening Phase (Screening and first assessment visit should preferably take place on the same day), active assessment phase (12 weeks, An optional 12 week extension phase. Participants will be assigned to Cohort 1, or randomized to Cohort 2 or Cohort 3. Participants in cohorts 2 and 3 who are receiving long acting injectable (LAI) formulations of paliperidone and/or risperidone and complete participation in the active assessment phase) will have the option of continuing into the extension phase. The duration of study participation will be approximately 12 weeks. Participants in the optional extension phase will have an additional 12 weeks of study participation. The primary outcome will be measured by the number of Medication Treatment Modifications (MTMs) made by the clinician at every visit. Participants' safety will be monitored throughout the study.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Aripiprazole, Olanzapine, Paliperidone, Quetiapine, Risperidone
- Keywords
- Schizophrenia, Schizoaffective Disorder, Aripiprazole, Olanzapine, Paliperidone, Quetiapine, Risperidone, Liquid Chromatography-Tandem Mass Spectrometry
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Participants will receive aripiprazole at a dose of 5 milligram (mg) or higher, as oral formulation once daily for 12 weeks as part of participant treatment.
OlanzapineDrug
Participants will receive olanzapine at a dose of 5 mg or higher, as oral formulation once daily for 12 weeks as part of participant treatment.
PaliperidoneDrug
Participants will receive paliperidone 3 mg or higher dose as oral formulation once daily or 39 mg or higher dose once every 4 weeks for 12 weeks as part of participant treatment.
QuetiapineDrug
Participants will receive quetiapine at a dose of 150 mg or higher, as oral formulation once daily for 12 weeks as part of participant treatment.
RisperidoneDrug
Participants will receive risperidone 1 mg or higher dose, as oral formulation once daily or as injection of 12.5 mg or higher dose once every 2 weeks for 12 weeks as part of participant treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks as determined by the treating clinician and the antipsychotic medication plasma level (AMPL) results will not be available to the clinicians until all participants in this cohort at a given site have completed their study participation. Receives: Drug: Aripiprazole; Drug: Olanzapine; Drug: Paliperidone; Drug: Quetiapine; Drug: Risperidone |
| Cohort 2 | Experimental | Participants will receive treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks as determined by the treating clinician and the antipsychotic medication plasma level (AMPL) results will be provided to the clinician as they become available. Receives: Drug: Aripiprazole; Drug: Olanzapine; Drug: Paliperidone; Drug: Quetiapine; Drug: Risperidone |
| Cohort 3 | Experimental | Participants will receive treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks as determined by the treating clinician and the antipsychotic medication plasma level (AMPL) results will not be available to the clinicians until all participants in cohorts 2 and 3 at a given site have completed participation in the active assessment phase. Receives: Drug: Aripiprazole; Drug: Olanzapine; Drug: Paliperidone; Drug: Quetiapine; Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Medication Treatment Modifications (MTM)
Information on MTMs derived from data collected in the clinical assessment of the schizophrenia patient (CASP) questionnaire. The CASP captured changes in medications, changes in psychosocial treatments, visit frequency, and the need for any acute interventions. The CASP comprised of 3 sections covering several parameters. The CASP captured changes in treatment options which was used to compute MTM, as well as factors in clinical decision making and the influence of antipsychotic medication plasma levels (AMPL), when they were available, on clinical decision making.
Measured: Up to Week 12
Secondary outcomes (7)
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Clinical Global Impression-Severity (CGI-S) rating scale used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.
Measured: Week 0, Week 12
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
The DPSS is a clinician-rated scale used to rate 8 domains commonly seen in patients with psychotic disorders. Each domain was rated on a 5-point scale (0 to 4) with anchored description of endpoints. Total score was computed by summing the scores of individual items (range of 0-32). Higher scores represent more severe condition. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.
Measured: Week 0, Week 12
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
AMPL of the individual participant during the active assessment phase was reported.
Measured: Week 12
Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
The CASP and data on concomitant medications and psychosocial treatments were used to evaluate the impact of AMPL results on other aspects of clinical decision making.
Measured: Up to Week 12
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
The CRS is an ordinal scale filled by the clinician. The scores range from 1 to 7 that were used to quantify the clinician's assessment of treatment adherence by the patient. Higher scores indicate greater adherence. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.
Measured: Week 0, Week 12
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
The BARS is a 4-item scale that includes 3 questions and an overall visual analog rating scale that assesses participant's knowledge about his/her medication. The key measure of adherence is the visual analog scale and assesses the percentage of doses taken by the participants in the past month (0 percent [%] - 100%). The 3 questions include: number of prescribed doses per day, number of days in the past month when the participant did not take the prescribed doses, and the number of days in the past month when the participant took less than the prescribed dose. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.
Measured: Week 0, Week 12
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
The PSS is a brief scale designed to capture a psychiatric patient's satisfaction with a clinician. The scale covers 6 domains: Trust (3 items), Communication (3 items), Exploration of Ideas/Options (2 items), Body Language (2 items), Active Listening (4 items), and Miscellaneous Items (6 items). Out of the 20 items, the first 19 are scored on a 5-point Likert Scale (1=strongly disagree, 2=disagree, 3=satisfactory, 4=agree, 5=strongly agree). The last question (6f) is a free-response question asking for input on how the clinician might improve. Sum of scores of individual items give a total score (range 9-95). Higher scores indicate greater degree of satisfaction. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.
Measured: Week 0, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Due to poor enrollment sponsor terminated early after enrolling 9 in Cohort 1 and no enrollment in Cohorts 2 and 3.
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.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462473
- Sponsor's protocol ID
- CR106922
- Other IDs
- CODX0001NAP2002
- Status last verified
- Feb 2017
- First submitted
- 2 Jun 2015
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential and Parallel Cohort Design to Test the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry
- ClinicalTrials.gov ID
- NCT02462473
- Acronym / sponsor ID
- CR106922
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective Disorder, Aripiprazole, Olanzapine, Paliperidone, Quetiapine, Risperidone, Liquid Chromatography-Tandem Mass Spectrometry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor enrollment sponsor terminated early after enrolling 9 in Cohort 1 and no enrollment in Cohorts 2 and 3.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Posted 29 Mar 2017
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 this study is to determine the number of Medication Treatment Modifications (MTMs) made by the clinician at every visit when antipsychotic medication plasma levels (AMPL) results are available compared to when AMPL results are not available.
Detailed description
This is a naturalistic, open-label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study), pilot clinical utility study with a sequential and parallel cohort design in participants with a diagnosis of schizophrenia or schizoaffective disorder. The study consists of up to 3 Phases: Screening Phase (Screening and first assessment visit should preferably take place on the same day), active assessment phase (12 weeks, An optional 12 week extension phase. Participants will be assigned to Cohort 1, or randomized to Cohort 2 or Cohort 3. Participants in cohorts 2 and 3 who are receiving long acting injectable (LAI) formulations of paliperidone and/or risperidone and complete participation in the active assessment phase) will have the option of continuing into the extension phase. The duration of study participation will be approximately 12 weeks. Participants in the optional extension phase will have an additional 12 weeks of study participation. The primary outcome will be measured by the number of Medication Treatment Modifications (MTMs) made by the clinician at every visit. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Aripiprazole, Drug: Olanzapine, Drug: Paliperidone, Drug: Quetiapine, Drug: RisperidoneParticipants will receive treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks as determined by the treating clinician and the antipsychotic medication plasma level (AMPL) results will not be available to the clinicians until all participants in this cohort at a given site have completed their study participation. |
| Cohort 2 | Experimental | Drug: Aripiprazole, Drug: Olanzapine, Drug: Paliperidone, Drug: Quetiapine, Drug: RisperidoneParticipants will receive treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks as determined by the treating clinician and the antipsychotic medication plasma level (AMPL) results will be provided to the clinician as they become available. |
| Cohort 3 | Experimental | Drug: Aripiprazole, Drug: Olanzapine, Drug: Paliperidone, Drug: Quetiapine, Drug: RisperidoneParticipants will receive treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks as determined by the treating clinician and the antipsychotic medication plasma level (AMPL) results will not be available to the clinicians until all participants in cohorts 2 and 3 at a given site have completed participation in the active assessment phase. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant has a diagnosis of schizophrenia (Code 295.90) or schizoaffective disorder (Code 295.70) according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM 5), based on history and clinical assessment by the investigator
- Participant has current active medication management issues and has experienced a medication treatment modification within the 6 weeks prior to Screening
- Participant is currently taking one or more of the following antipsychotic medications for at least 1 week for oral antipsychotics and at least 1 injection cycle for long-acting injectable (LAI) antipsychotics. In addition, the treating clinician plans to continue the antipsychotic medication(s) for at least 4 weeks subsequent to the Screening visit. Participant may be taking more than one formulation of a particular medication (such as oral and LAI) at or above the minimum dose specified in protocol. Qualifying formulations of the antipsychotic medications are: Aripiprazole (oral formulation only), Olanzapine (oral formulation only), Paliperidone (oral and/or LAI formulations), Quetiapine (oral formulation only), and Risperidone (oral and/or LAI formulations)
- Participant has had no clinically significant suicidal behavior or ideation during the week prior to Screening, according to the investigator's judgment
- Participant is generally healthy and has no clinically significant or unstable medical problems as determined by the investigator, except for the indication for which the antipsychotic treatment is being prescribed. This determination must be recorded in the participant's source documents and initialed by the investigator
Key exclusion criteria (5 listed)
- Participant has been attending the outpatient psychiatric clinic for more than 12 months since the last psychiatric hospitalization
- During Screening, participant has active alcohol or substance use disorder (except tobacco) of moderate or severe severity according to DSM 5 criteria
- Participant has a history of or currently has a clinically significant (particularly unstable) medical illness, other than the indication for which the participant is taking antipsychotic therapy, that the investigator considers should exclude the participant or that could interfere with the participant completing the study or with interpretation of the study results. Treated, stable, chronic medical problems are allowed, as long as these conditions do not interfere with the study assessments
- Participant is receiving clozapine
- Participant has donated blood or blood products or had substantial loss of blood (ie, blood loss of approximately more than 450 milliliter (mL) or blood loss that required a blood transfusion) within 1 month of Screening or has the intention to donate blood or blood products during the study
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 |
|---|---|---|
| AripiprazoleParticipants will receive aripiprazole at a dose of 5 milligram (mg) or higher, as oral formulation once daily for 12 weeks as part of participant treatment. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| OlanzapineParticipants will receive olanzapine at a dose of 5 mg or higher, as oral formulation once daily for 12 weeks as part of participant treatment. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PaliperidoneParticipants will receive paliperidone 3 mg or higher dose as oral formulation once daily or 39 mg or higher dose once every 4 weeks for 12 weeks as part of participant treatment. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| QuetiapineParticipants will receive quetiapine at a dose of 150 mg or higher, as oral formulation once daily for 12 weeks as part of participant treatment. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| RisperidoneParticipants will receive risperidone 1 mg or higher dose, as oral formulation once daily or as injection of 12.5 mg or higher dose once every 2 weeks for 12 weeks as part of participant treatment. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of Participants With Medication Treatment Modifications (MTM)
Time frame: Up to Week 12
Information on MTMs derived from data collected in the clinical assessment of the schizophrenia patient (CASP) questionnaire. The CASP captured changes in medications, changes in psychosocial treatments, visit frequency, and the need for any acute interventions. The CASP comprised of 3 sections covering several parameters. The CASP captured changes in treatment options which was used to compute MTM, as well as factors in clinical decision making and the influence of antipsychotic medication plasma levels (AMPL), when they were available, on clinical decision making.
7 secondary outcomes
Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
Time frame: Week 0, Week 12
Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
Time frame: Week 0, Week 12
Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
Time frame: Week 12
Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
Time frame: Up to Week 12
Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
Time frame: Week 0, Week 12
Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
Time frame: Week 0, Week 12
Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
Time frame: Week 0, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
3 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 Aripiprazole, Olanzapine and Paliperidone in people with Schizophrenia and Schizoaffective Disorder, run by Janssen Research & Development, LLC at 3 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: stopped early, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Yes. Results are posted in the registry (first posted 29 Mar 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?
Number of Participants With Medication Treatment Modifications (MTM) (time frame: Up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2017.