SchizophreniaPhase 3RAPSODINCT03043820
Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder
A Phase 3 study testing Raloxifene in people with Schizophrenia and Schizoaffective Disorder, run by Iris Sommer at 1 site in Netherlands.
Trial summary
There is increasing clinical and molecular evidence for the role of hormones and specifically estrogen and its receptor in schizophrenia. A selective estrogen receptor modulator, raloxifene, stimulates estrogen-like activity in brain and can improve cognition in older adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- What is being tested?
- Raloxifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2016to 1 Jul 2021
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychotic disorder NOS)
- Capable of understanding the purpose and details of the study in order to provide written informed consent;
- On a stable dose of antipsychotic medication for at least two weeks;
- For female patients:
- Female patients who are sexually active must be willing and capable to use a non-estrogenic contraceptive (intrauterine device, cervical cap, condom or diaphragm) in case of sexual intercourse for the complete duration of the study;
- Female patients with post coital uterine bleeding must have documented normal PAP smear and pelvic examination in the preceding two years.
Who cannot join
- Pre-existing cardiovascular disease;
- History of thrombo-embolic events;
- History of breast cancer;
- Familial tendency to form blood clots (such as familial factor V Leiden);
- Use of vitamin K antagonists;
- Use of cholestyramine or other anion exchange resins;
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- Hypertriglyceridemia (triglycerides > 3 times the upper limit of normal (ULN));
- Liver function or enzyme disorders (serum bilirubin, alkaline phosphatase (AF), gamma-glutamyl transpeptidase (γ - GT), aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 3 times the ULN as measured at baseline);
- Severe kidney failure (eGFR <30 ml/min as measured at baseline);
- Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet in the past three months.
- For female patients:
- Abnormality observed during physical breast examination;
- Pregnancy or breast feeding;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder to Reduce Symptoms and Improve Cognition
There is increasing clinical and molecular evidence for the role of hormones and specifically estrogen and its receptor in schizophrenia. A selective estrogen receptor modulator, raloxifene, stimulates estrogen-like activity in brain and can improve cognition in older adults. The present study will test the extent to which adjunctive raloxifene treatment improved cognition and reduced symptoms in young to middle-age men and women with schizophrenia.
110 patients with a schizophrenia spectrum disorder will be recruited in a multicenter twelve-week, randomized, double-blind, placebo-controlled, parallel trial of adjunctive 120mg raloxifene treatment in addition to their usual antipsychotic medications.
The investigators hypothesize that daily treatment with raloxifene 120 milligrams (mg) in addition to antipsychotic treatment improves cognition, reduces psychotic symptoms, increases social and personal functioning and reduces health care costs, as compared to placebo.
Read the detailed description
Rationale:
Patients with a schizophrenia spectrum disorder experience substantial impairments in multiple domains of everyday life, including the ability to maintain social relationships, sustain employment, and live independently. These problems often persist, even after successful treatment of psychosis. Currently, no consistent evidence exists for the efficacy of interventions to reduce cognitive and negative symptoms, while in fact these are the factors that determine functioning to a great extent.
Premenopausal women with schizophrenia have less psychotic and negative symptoms, and better cognitive and social functioning, in comparison to men and older women. This has been related to protective effects of estrogens in the brain. Administering estrogens has positive effects on psychotic symptoms, but exerts long-term side effects, especially in men.
Raloxifene is a selective estrogen receptor modulator, with a beneficial side effect profile in women and in men. It has been shown to be effective in reducing symptoms in postmenopausal women with schizophrenia. Recently, positive results were found in premenopausal women and in men. It is important to replicate these results in an independent sample and to investigate the effects of raloxifene on functioning.
Hypotheses: Daily treatment with raloxifene 120 milligrams (mg) in addition to antipsychotic treatment improves cognition, reduces psychotic symptoms, increases social and personal functioning and reduces health care costs, as compared to placebo.
Objective:
The primary objective of this trial is to investigate the hypothesized beneficial effect of raloxifene as compared to placebo when given for twelve weeks in addition to antipsychotic medication to patients with a psychotic disorder. The investigators expect lower symptom severity as measured with the Positive And Negative Symptom Scale (PANSS) and improvements of cognitive functioning as measured with the Brief Assessment of Cognition in Schizophrenia (BACS).
Secondary objectives include reducement of negative symptoms as measured with the Brief Negative Symptom Scale (BNSS), improvement of Personal and Social Performance (using the PSP-scale), reduction of thought disorder symptoms measures with the Thought And Language Disorder-scale (TALD), reduction use of health care recourses using the institute for Medical Technology Assessment's Medical Consumption Questionnaire (iMTA-MCQ), productivity using the institute for Medical Technology Assessment's Productivity Cost Questionnaire (iMTA-PCQ), improvement of quality of life using the EuroQol-5 dimensions scale (EQ-5D), improvement in both speed and error rates in the Stroop test, reduction of comorbid depression using Beck's Depression Inventory (BDI), improvement of language production and various hormonal and inflammatory parameters.
Study design: Randomized placebo-controlled multicenter double-blind trial
Study population:
110 men and women diagnosed with schizophrenia, schizoaffective or schizophreniform disorder, or psychotic disorder not otherwise specified (DSM-IV 295.*)
Intervention:
Patients will be randomized 1:1 to either 120mg raloxifene or placebo daily for a period of 12 weeks. Identical tablets will be administered.
Main study parameters/endpoints:
Primary outcomes are changes in symptom severity as measured with PANSS and changes in cognition as measured with BACS. Secondary outcome are changes in negative symptoms (measured with BNSS), changes in personal and social performance (measured with PSP), change in severity of thought disorder (measured with TALD), quality of life (measured with EQ-5D), use of healthcare and non-healthcare resources, comorbid depression (measured with BDI), cognitive control (measured with a Stroop Test), language production (measured by analyzing speech samples) and hormonal and inflammatory biomarkers.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Use of raloxifene is associated with a small risk of side effects. The number of patient visits will be limited and mainly requires time invested for physical examinations, questionnaires and cognitive testing sessions (around 9 hours in total over the course of 9 months). Blood will be drawn at three occasions with negligible and known risks (e.g. irritation). The burden and risks are acceptable while the benefits are expected to be considerable.
- Being tested
- Raloxifene, Placebo
- Keywords
- raloxifene, selective estrogen receptor modulator (SERM), schizophrenia, psychosis, cognition, negative symptoms
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaloxifeneDrug
Also called Evista
Oral selective estrogen receptor modulator (SERM).
PlaceboDrug
Tablets identical in form and color to intervention.
| Study group | Role | What they receive |
|---|---|---|
| Raloxifene | Active comparator | Raloxifene 120 mg (2 tablets of 60mg) daily for 12 weeks. Receives: Drug: Raloxifene |
| Placebo | Placebo comparator | Placebo 2 tablets daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom severity as measured with the Positive and Negative Symptom Scale (PANSS)
Effect of the study therapies on symptom severity.
Measured: Baseline, at 6 weeks of treatment, at 12 weeks of treatment (end of treatment) and 6 months after end of treatment (follow-up)
Change in cognitive functioning as measured with the Brief Assessment of Cognition in Schizophrenia
Effect of the study therapies on cognitive functioning
Measured: Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Secondary outcomes (8)
Personal and social performance measured with the Personal and Social Performance scale (PSP)
Effect of the study therapy on personal and social performance.
Measured: Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Thought disorder severity as measured with the Thought And Language Disorder scale (TALD)
Effect of the study therapy on severity of thought disorder.
Measured: Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Participant's Quality of Life as measured with the EQ-5D-5L
Effect of the study therapy on quality of life.
Measured: Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Comorbid depression as measured with Beck's Depression Inventory (BDI).
Effect of the study therapy on comorbid depression
Measured: Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Use of health-recourses as measured with the iMTA-MCQ
Effect of the study therapy on use of recourses.
Measured: Baseline, at 12 weeks (end of treatment) and 6 months follow-up
Use of non-health recourses as measured with the iMTA-PCQ
Effect of the study therapy on use of recourses.
Measured: Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Language production assessment by analyzing speech samples
Effect of the study therapy on free speech.
Measured: Baseline and at 12 weeks of treatment (end of treatment)
Symptom severity as measured with the Brief Negative Symptom Scale (BNSS)
Effect of the study therapies on symptom severity.
Measured: Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study startAug 2016
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iris Sommer
- Sponsor type
- University, hospital or other
- Collaborators
- Julius Center, Rudolf Magnus Institute - University of Utrecht, GGZ Eindhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), GGZ Centraal, Altrecht GGZ, Reinier van Arkel Group, Ziekenhuis Netwerk Antwerpen (ZNA)
- Responsible party
- Sponsor-investigator, Iris Sommer, UMC Utrecht
- Investigators
- Iris Sommer, Prof. dr., Principal investigator, UMC GroningenBob Oranje, Ass. Prof., Principal investigator, UMC UtrechtJanna de Boer, MD, Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043820
- Sponsor's protocol ID
- NL.55343.041.16
- Other IDs
- 2015-004483-11, 80-83600-98-40120, 2015
- Acronym
- RAPSODI
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2016
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Heringa SM, Begemann MJ, Goverde AJ, Sommer IE. Sex hormones and oxytocin augmentation strategies in schizophrenia: A quantitative review. Schizophr Res. 2015 Nov;168(3):603-13. doi: 10.1016/j.schres.2015.04.002. Epub 2015 Apr 23.
PubMed 25914107
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder to Reduce Symptoms and Improve Cognition
- ClinicalTrials.gov ID
- NCT03043820
- Acronym / sponsor ID
- RAPSODI / NL.55343.041.16
- Keywords
- raloxifene, selective estrogen receptor modulator (SERM), schizophrenia, psychosis, cognition, negative symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Iris SommerUniversity, hospital or other
- Collaborators
- Julius Center, Rudolf Magnus Institute - University of Utrecht, GGZ Eindhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), GGZ Centraal, Altrecht GGZ, Reinier van Arkel Group, Ziekenhuis Netwerk Antwerpen (ZNA)
- Study start
- Aug 2016 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 6 Feb 2017 (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.
There is increasing clinical and molecular evidence for the role of hormones and specifically estrogen and its receptor in schizophrenia. A selective estrogen receptor modulator, raloxifene, stimulates estrogen-like activity in brain and can improve cognition in older adults. The present study will test the extent to which adjunctive raloxifene treatment improved cognition and reduced symptoms in young to middle-age men and women with schizophrenia.
110 patients with a schizophrenia spectrum disorder will be recruited in a multicenter twelve-week, randomized, double-blind, placebo-controlled, parallel trial of adjunctive 120mg raloxifene treatment in addition to their usual antipsychotic medications.
The investigators hypothesize that daily treatment with raloxifene 120 milligrams (mg) in addition to antipsychotic treatment improves cognition, reduces psychotic symptoms, increases social and personal functioning and reduces health care costs, as compared to placebo.
Detailed description
Rationale:
Patients with a schizophrenia spectrum disorder experience substantial impairments in multiple domains of everyday life, including the ability to maintain social relationships, sustain employment, and live independently. These problems often persist, even after successful treatment of psychosis. Currently, no consistent evidence exists for the efficacy of interventions to reduce cognitive and negative symptoms, while in fact these are the factors that determine functioning to a great extent.
Premenopausal women with schizophrenia have less psychotic and negative symptoms, and better cognitive and social functioning, in comparison to men and older women. This has been related to protective effects of estrogens in the brain. Administering estrogens has positive effects on psychotic symptoms, but exerts long-term side effects, especially in men.
Raloxifene is a selective estrogen receptor modulator, with a beneficial side effect profile in women and in men. It has been shown to be effective in reducing symptoms in postmenopausal women with schizophrenia. Recently, positive results were found in premenopausal women and in men. It is important to replicate these results in an independent sample and to investigate the effects of raloxifene on functioning.
Hypotheses: Daily treatment with raloxifene 120 milligrams (mg) in addition to antipsychotic treatment improves cognition, reduces psychotic symptoms, increases social and personal functioning and reduces health care costs, as compared to placebo.
Objective:
The primary objective of this trial is to investigate the hypothesized beneficial effect of raloxifene as compared to placebo when given for twelve weeks in addition to antipsychotic medication to patients with a psychotic disorder. The investigators expect lower symptom severity as measured with the Positive And Negative Symptom Scale (PANSS) and improvements of cognitive functioning as measured with the Brief Assessment of Cognition in Schizophrenia (BACS).
Secondary objectives include reducement of negative symptoms as measured with the Brief Negative Symptom Scale (BNSS), improvement of Personal and Social Performance (using the PSP-scale), reduction of thought disorder symptoms measures with the Thought And Language Disorder-scale (TALD), reduction use of health care recourses using the institute for Medical Technology Assessment's Medical Consumption Questionnaire (iMTA-MCQ), productivity using the institute for Medical Technology Assessment's Productivity Cost Questionnaire (iMTA-PCQ), improvement of quality of life using the EuroQol-5 dimensions scale (EQ-5D), improvement in both speed and error rates in the Stroop test, reduction of comorbid depression using Beck's Depression Inventory (BDI), improvement of language production and various hormonal and inflammatory parameters.
Study design: Randomized placebo-controlled multicenter double-blind trial
Study population:
110 men and women diagnosed with schizophrenia, schizoaffective or schizophreniform disorder, or psychotic disorder not otherwise specified (DSM-IV 295.*)
Intervention:
Patients will be randomized 1:1 to either 120mg raloxifene or placebo daily for a period of 12 weeks. Identical tablets will be administered.
Main study parameters/endpoints:
Primary outcomes are changes in symptom severity as measured with PANSS and changes in cognition as measured with BACS. Secondary outcome are changes in negative symptoms (measured with BNSS), changes in personal and social performance (measured with PSP), change in severity of thought disorder (measured with TALD), quality of life (measured with EQ-5D), use of healthcare and non-healthcare resources, comorbid depression (measured with BDI), cognitive control (measured with a Stroop Test), language production (measured by analyzing speech samples) and hormonal and inflammatory biomarkers.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Use of raloxifene is associated with a small risk of side effects. The number of patient visits will be limited and mainly requires time invested for physical examinations, questionnaires and cognitive testing sessions (around 9 hours in total over the course of 9 months). Blood will be drawn at three occasions with negligible and known risks (e.g. irritation). The burden and risks are acceptable while the benefits are expected to be considerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raloxifene | Active comparator | Drug: RaloxifeneRaloxifene 120 mg (2 tablets of 60mg) daily for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 2 tablets daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychotic disorder NOS)
- Capable of understanding the purpose and details of the study in order to provide written informed consent;
- On a stable dose of antipsychotic medication for at least two weeks;
- Female patients who are sexually active must be willing and capable to use a non-estrogenic contraceptive (intrauterine device, cervical cap, condom or diaphragm) in case of sexual intercourse for the complete duration of the study;
- Female patients with post coital uterine bleeding must have documented normal PAP smear and pelvic examination in the preceding two years.
Key exclusion criteria (13 listed)
- Pre-existing cardiovascular disease;
- History of thrombo-embolic events;
- History of breast cancer;
- Familial tendency to form blood clots (such as familial factor V Leiden);
- Use of vitamin K antagonists;
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 |
|---|---|---|
| RaloxifeneAlso: EvistaOral selective estrogen receptor modulator (SERM). | Drug | Raloxifene |
| PlaceboTablets identical in form and color to intervention. | Drug | Placebo |
Primary outcome
Change in symptom severity as measured with the Positive and Negative Symptom Scale (PANSS)
Time frame: Baseline, at 6 weeks of treatment, at 12 weeks of treatment (end of treatment) and 6 months after end of treatment (follow-up)
Effect of the study therapies on symptom severity.
Change in cognitive functioning as measured with the Brief Assessment of Cognition in Schizophrenia
Time frame: Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Effect of the study therapies on cognitive functioning
8 secondary outcomes
Personal and social performance measured with the Personal and Social Performance scale (PSP)
Time frame: Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Thought disorder severity as measured with the Thought And Language Disorder scale (TALD)
Time frame: Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Participant's Quality of Life as measured with the EQ-5D-5L
Time frame: Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Comorbid depression as measured with Beck's Depression Inventory (BDI).
Time frame: Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Use of health-recourses as measured with the iMTA-MCQ
Time frame: Baseline, at 12 weeks (end of treatment) and 6 months follow-up
Use of non-health recourses as measured with the iMTA-PCQ
Time frame: Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
Language production assessment by analyzing speech samples
Time frame: Baseline and at 12 weeks of treatment (end of treatment)
Symptom severity as measured with the Brief Negative Symptom Scale (BNSS)
Time frame: Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)
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 8 Oct 2021.
- Background: PubMed 25914107Heringa SM, Begemann MJ, Goverde AJ, Sommer IE. Sex hormones and oxytocin augmentation strategies in schizophrenia: A quantitative review. Schizophr Res. 2015 Nov;168(3):603-13. doi: 10.1016/j.schres.2015.04.002. Epub 2015 Apr 23.
- Individual participant dataSharing planned: Undecided
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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.
Iris Sommer, Prof. dr. principal investigator
UMC Groningen
Bob Oranje, Ass. Prof. principal investigator
UMC Utrecht
Janna de Boer, MD study chair
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Raloxifene in people with Schizophrenia and Schizoaffective Disorder, run by Iris Sommer at 1 site in Netherlands.
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 6 inclusion and 13 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 8 Oct 2021. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in symptom severity as measured with the Positive and Negative Symptom Scale (PANSS) (time frame: Baseline, at 6 weeks of treatment, at 12 weeks of treatment (end of treatment) and 6 months after end of treatment (follow-up)). The study lists 2 primary outcomes in all. 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 NCT03043820, which also lists 1 linked publication.
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 8 Oct 2021.