Bipolar DepressionPhase 4NCT00384332
Medication, Weight Gain and GI Hormones
A Phase 4 study testing orally-disintegrating olanzapine and regular olanzapine in people with Bipolar Depression, run by Vanderbilt University at 1 site in United States.
Trial summary
This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg daily) whereas the other medication is an orally disintegrating medication. Both medications are used to treat depressed bipolar patients. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- orally-disintegrating olanzapine and regular olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2010
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A principal diagnosis of bipolar 1 or II disorder
- Ages 18-60
- Physically healthy
- Outpatient status
- Montgomery-Asberg Rating Scale (MADRS) Score greater than or equal to 15
- BMI 23-30
- Able and willing to give written informed consent
Who cannot join
- Prior history of diabetes (types I or II)
- BMI>30
- Non-fasting blood glucose >124
- Fasting blood glucose >125 or random blood glucose >200
- Presence of dyslipidemia (baseline total cholesterol >240, HDL<50, LDL>160, triglycerides >199)
- Current or past history of a non-affective psychotic disorder
Show all 20Show fewer
- Alcohol or other substance abuse or dependence in the 6 months prior to the evaluation (except for caffeine)
- Current use of any nicotine products
- Schizoid, schizotypal, or borderline personality disorder
- Treatment with olanzapine in the prior 3 months or any history of non- response to or intolerance of olanzapine or the olanzapine-fluoxetine combination (SymbiaxTM)
- Suicide potential that, in the opinion of the investigator, precludes outpatient treatment or participation in a trial
- Participation of subjects in another drug trial within 30 days of evaluation
- The presence of any current medical condition judged by the investigator to potentially interfere with the study procedures or measures
- The likelihood of requiring hospitalization over the period of the study
- The presence of any clinically-significant laboratory abnormality as judged by the investigator
- Pregnancy or lactation
- History of seizure disorder, excluding febrile seizures of childhood
- Any disorder of taste or smell, including severe nasal allergies
- Any other condition which, in the investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study
- Being unable to comprehend or follow the study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Orally-Disintegrating vs. Regular Olanzapine Tablets: Effects on Weight and GI Hormones
This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg daily) whereas the other medication is an orally disintegrating medication. Both medications are used to treat depressed bipolar patients. The main focus of this study is the comparison of these two medications on gastro-intestinal hormones and weight gain.
Read the detailed description
Olanzapine is undeniably one of the most effective treatments available for all phases of bipolar disorder. After FDA approval for bipolar mania, the drug became one of the most widely prescribed of treatments for this difficult-to-treat disorder. However, concerns about weight gain and the associated metabolic syndrome/type II diabetes have impacted the use of olanzapine.
In fact, weight gain is quite common with olanzapine. For example, in one large scale 8-week placebo-controlled trial of olanzapine in bipolar depression, the olanzapine-treated patients gained an average of 2.59 kg., while placebo patients lost an average of 0.47 kg. Further, weight gain can continue over an extended period of time, mounting to an average of about 6 kg. over one year. It should be noted, however, that in prior studies, no efforts have been made to limit weight gain. More recent data suggest that interventions such as dietary counseling are effective in either preventing or reversing weight gain.
Olanzapine is a potent antagonist of serotonin and histamine 1 receptors. Significant and potentially additive weight gain is associated with blockade of serotonin 2C and Histamine 1 receptors. In addition, serotonin and its receptors are significantly involved in the regulation of gastrointestinal (GI) - related hormone secretion. Animal studies suggest significant involvement of other serotonin receptors in the regulation of appetite, satiety, and GI-related hormones. However, the interplay of selective activation or inhibition of these receptor subtypes is complex, and difficult to distinguish from effects on activity and anxiety. Suffice it to say that activation or blockade of these receptors have differential effects on appetite, satiety, metabolic activity, as well as leptin, secretin, insulin, glucagon, ghrelin, neuropeptide Y, and cholecystokinin.
Weight gain and the corresponding metabolic syndrome represent a "deal killer" with regard to the treatment of most patients. However, one recent small study may be highly relevant to this discussion. De Haan et al. investigated the relative effects of standard olanzapine tablets to the orally-disintegrating form (Zydis) in adolescents and young adults who had gained weight with olanzapine. The group randomly assigned 18 patients to continuation olanzapine tablets or Zydis for a 16-week period. The Zydis-treated patients lost an average of 6.6 kg. while the continuation regular olanzapine group gained 3.7 kg. Although small, this study suggests a potential solution to the weight-gain problem associated with olanzapine.
Most of the pharmacological effects on weight and hormones are thought to be mediated centrally. However, De Haan et al. (de Haan L, et al. Psychopharmacology (Berl). 2004;175:389-390) proposed that at least some of the difference could be attributable to local effects in the GI tract. In particular, the site of absorption was suggested as a possible explanation, with the orally disintegrating form (Zydis) yielding less exposure of the pylorus to olanzapine than the standard Zyprexa tablets.
In this project we will treat 20 patients with bipolar disorder with olanzapine (a widely-used and FDA approved treatment for this condition); patients will be randomly assigned (1:1) to either standard Zyprexa tablets or orally disintegrating Zydis. We will measure symptom improvement and weight gain over the course of the study. Patients will be given dietary counseling prior to initiating either medication. In addition, we will contrast the effects of the treatments on GI-related hormones.
- Conditions
- Bipolar Depression
- Being tested
- orally-disintegrating olanzapine, regular olanzapine
- Keywords
- Bipolar Depression, Weight gain bipolar medicine, side effects olanzapine, gastrointestinal hormones bipolar medicine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orally-disintegrating olanzapineDrug
Also called Zydis
5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.
regular olanzapineDrug
Also called Zyprexa
5-20 mg. olanzapine daily for approximately 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Orally disintegrating olanzapine Receives: Drug: orally-disintegrating olanzapine |
| Arm 2 | Experimental | regular olanzapine Receives: Drug: regular olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8
Change in weight from baseline to endpoint in kilograms. Reported as weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8
Measured: 10 weeks
Secondary outcomes (1)
Change From Baseline Montgomery Asberg Depression Rating Scale
Montgomery Asberg Depression Rating Scale (MADRS) total score. Construct: Depression severity. Scores below represent mean change scores, endpoint minus baseline. Minimum total score: 0 (no depression). Maximum total score: 60 (severe depression). Lower (more negative) scores indicate a better outcome. There are no subscales.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startJan 2007
- Primary completionMar 2010
- Study completionMar 2010
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 (11)Papers the sponsor has linked to this study.
- Other trials for Bipolar DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Richard C. Shelton, Vanderbilt University
- Investigators
- Richard C. Shelton, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384332
- Sponsor's protocol ID
- 051235
- Status last verified
- Jun 2017
- First submitted
- 4 Oct 2006
- Last updated
- 31 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tohen M, Vieta E, Calabrese J, Ketter TA, Sachs G, Bowden C, Mitchell PB, Centorrino F, Risser R, Baker RW, Evans AR, Beymer K, Dube S, Tollefson GD, Breier A. Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry. 2003 Nov;60(11):1079-88. doi: 10.1001/archpsyc.60.11.1079.
PubMed 14609883Shelton RC. Treating bipolar depression. J Fam Pract. 2003 Mar;Suppl:S14-7. No abstract available.
PubMed 12676079Farwell WR, Stump TE, Wang J, Tafesse E, L'Italien G, Tierney WM. Weight gain and new onset diabetes associated with olanzapine and risperidone. J Gen Intern Med. 2004 Dec;19(12):1200-5. doi: 10.1111/j.1525-1497.2004.40126.x.
PubMed 15610330eder-Ischia U, Ebenbichler C, Fleischhacker WW. Olanzapine-induced weight gain and disturbances of lipid and glucose metabolism. Essent Psychopharmacol. 2005;6(2):112-7.
PubMed 15765795Smith RC, Lindenmayer JP, Bark N, Warner-Cohen J, Vaidhyanathaswamy S, Khandat A. Clozapine, risperidone, olanzapine, and conventional antipsychotic drug effects on glucose, lipids, and leptin in schizophrenic patients. Int J Neuropsychopharmacol. 2005 Jun;8(2):183-94. doi: 10.1017/S1461145705005110.
PubMed 15737248Cohen D. Diabetes mellitus during olanzapine and quetiapine treatment in Japan. J Clin Psychiatry. 2005 Feb;66(2):265-6; author reply 266-7. doi: 10.4088/jcp.v66n0217b. No abstract available.
PubMed 15705015Gill SS. Stable monotherapy with clozapine or olanzapine increases the incidence of diabetes mellitus in people with schizophrenia. Evid Based Ment Health. 2005 Feb;8(1):24. doi: 10.1136/ebmh.8.1.24. No abstract available.
PubMed 15671515Zimmermann U, Kraus T, Himmerich H, Schuld A, Pollmacher T. Epidemiology, implications and mechanisms underlying drug-induced weight gain in psychiatric patients. J Psychiatr Res. 2003 May-Jun;37(3):193-220. doi: 10.1016/s0022-3956(03)00018-9.
PubMed 12650740Tecott LH, Sun LM, Akana SF, Strack AM, Lowenstein DH, Dallman MF, Julius D. Eating disorder and epilepsy in mice lacking 5-HT2c serotonin receptors. Nature. 1995 Apr 6;374(6522):542-6. doi: 10.1038/374542a0.
PubMed 7700379Kroeze WK, Hufeisen SJ, Popadak BA, Renock SM, Steinberg S, Ernsberger P, Jayathilake K, Meltzer HY, Roth BL. H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs. Neuropsychopharmacology. 2003 Mar;28(3):519-26. doi: 10.1038/sj.npp.1300027.
PubMed 12629531Bobo WV, Epstein RA Jr, Shelton RC. Effects of orally disintegrating vs regular olanzapine tablets on body weight, eating behavior, glycemic and lipid indices, and gastrointestinal hormones: a randomized, open comparison in outpatients with bipolar depression. Ann Clin Psychiatry. 2011 Aug;23(3):193-201.
PubMed 21808751
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orally-Disintegrating vs. Regular Olanzapine Tablets: Effects on Weight and GI Hormones
- ClinicalTrials.gov ID
- NCT00384332
- Acronym / sponsor ID
- 051235
- Conditions
- Bipolar Depression
- Keywords
- Bipolar Depression, Weight gain bipolar medicine, side effects olanzapine, gastrointestinal hormones bipolar medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jan 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Posted 31 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg daily) whereas the other medication is an orally disintegrating medication. Both medications are used to treat depressed bipolar patients. The main focus of this study is the comparison of these two medications on gastro-intestinal hormones and weight gain.
Detailed description
Olanzapine is undeniably one of the most effective treatments available for all phases of bipolar disorder. After FDA approval for bipolar mania, the drug became one of the most widely prescribed of treatments for this difficult-to-treat disorder. However, concerns about weight gain and the associated metabolic syndrome/type II diabetes have impacted the use of olanzapine.
In fact, weight gain is quite common with olanzapine. For example, in one large scale 8-week placebo-controlled trial of olanzapine in bipolar depression, the olanzapine-treated patients gained an average of 2.59 kg., while placebo patients lost an average of 0.47 kg. Further, weight gain can continue over an extended period of time, mounting to an average of about 6 kg. over one year. It should be noted, however, that in prior studies, no efforts have been made to limit weight gain. More recent data suggest that interventions such as dietary counseling are effective in either preventing or reversing weight gain.
Olanzapine is a potent antagonist of serotonin and histamine 1 receptors. Significant and potentially additive weight gain is associated with blockade of serotonin 2C and Histamine 1 receptors. In addition, serotonin and its receptors are significantly involved in the regulation of gastrointestinal (GI) - related hormone secretion. Animal studies suggest significant involvement of other serotonin receptors in the regulation of appetite, satiety, and GI-related hormones. However, the interplay of selective activation or inhibition of these receptor subtypes is complex, and difficult to distinguish from effects on activity and anxiety. Suffice it to say that activation or blockade of these receptors have differential effects on appetite, satiety, metabolic activity, as well as leptin, secretin, insulin, glucagon, ghrelin, neuropeptide Y, and cholecystokinin.
Weight gain and the corresponding metabolic syndrome represent a "deal killer" with regard to the treatment of most patients. However, one recent small study may be highly relevant to this discussion. De Haan et al. investigated the relative effects of standard olanzapine tablets to the orally-disintegrating form (Zydis) in adolescents and young adults who had gained weight with olanzapine. The group randomly assigned 18 patients to continuation olanzapine tablets or Zydis for a 16-week period. The Zydis-treated patients lost an average of 6.6 kg. while the continuation regular olanzapine group gained 3.7 kg. Although small, this study suggests a potential solution to the weight-gain problem associated with olanzapine.
Most of the pharmacological effects on weight and hormones are thought to be mediated centrally. However, De Haan et al. (de Haan L, et al. Psychopharmacology (Berl). 2004;175:389-390) proposed that at least some of the difference could be attributable to local effects in the GI tract. In particular, the site of absorption was suggested as a possible explanation, with the orally disintegrating form (Zydis) yielding less exposure of the pylorus to olanzapine than the standard Zyprexa tablets.
In this project we will treat 20 patients with bipolar disorder with olanzapine (a widely-used and FDA approved treatment for this condition); patients will be randomly assigned (1:1) to either standard Zyprexa tablets or orally disintegrating Zydis. We will measure symptom improvement and weight gain over the course of the study. Patients will be given dietary counseling prior to initiating either medication. In addition, we will contrast the effects of the treatments on GI-related hormones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: orally-disintegrating olanzapineOrally disintegrating olanzapine |
| Arm 2 | Experimental | Drug: regular olanzapineregular olanzapine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- A principal diagnosis of bipolar 1 or II disorder
- Ages 18-60
- Physically healthy
- Outpatient status
- Montgomery-Asberg Rating Scale (MADRS) Score greater than or equal to 15
Key exclusion criteria (20 listed)
- Prior history of diabetes (types I or II)
- BMI>30
- Non-fasting blood glucose >124
- Fasting blood glucose >125 or random blood glucose >200
- Presence of dyslipidemia (baseline total cholesterol >240, HDL<50, LDL>160, triglycerides >199)
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 |
|---|---|---|
| orally-disintegrating olanzapineAlso: Zydis5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks. | Drug | Arm 1 |
| regular olanzapineAlso: Zyprexa5-20 mg. olanzapine daily for approximately 8 weeks. | Drug | Arm 2 |
Primary outcome
Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8
Time frame: 10 weeks
Change in weight from baseline to endpoint in kilograms. Reported as weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8
1 secondary outcome
Change From Baseline Montgomery Asberg Depression Rating Scale
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14609883Tohen M, Vieta E, Calabrese J, Ketter TA, Sachs G, Bowden C, Mitchell PB, Centorrino F, Risser R, Baker RW, Evans AR, Beymer K, Dube S, Tollefson GD, Breier A. Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry. 2003 Nov;60(11):1079-88. doi: 10.1001/archpsyc.60.11.1079.
- Background: PubMed 12676079Shelton RC. Treating bipolar depression. J Fam Pract. 2003 Mar;Suppl:S14-7. No abstract available.
- Background: PubMed 15610330Farwell WR, Stump TE, Wang J, Tafesse E, L'Italien G, Tierney WM. Weight gain and new onset diabetes associated with olanzapine and risperidone. J Gen Intern Med. 2004 Dec;19(12):1200-5. doi: 10.1111/j.1525-1497.2004.40126.x.
- Background: PubMed 15765795eder-Ischia U, Ebenbichler C, Fleischhacker WW. Olanzapine-induced weight gain and disturbances of lipid and glucose metabolism. Essent Psychopharmacol. 2005;6(2):112-7.
- Background: PubMed 15737248Smith RC, Lindenmayer JP, Bark N, Warner-Cohen J, Vaidhyanathaswamy S, Khandat A. Clozapine, risperidone, olanzapine, and conventional antipsychotic drug effects on glucose, lipids, and leptin in schizophrenic patients. Int J Neuropsychopharmacol. 2005 Jun;8(2):183-94. doi: 10.1017/S1461145705005110.
- Background: PubMed 15705015Cohen D. Diabetes mellitus during olanzapine and quetiapine treatment in Japan. J Clin Psychiatry. 2005 Feb;66(2):265-6; author reply 266-7. doi: 10.4088/jcp.v66n0217b. No abstract available.
- Background: PubMed 15671515Gill SS. Stable monotherapy with clozapine or olanzapine increases the incidence of diabetes mellitus in people with schizophrenia. Evid Based Ment Health. 2005 Feb;8(1):24. doi: 10.1136/ebmh.8.1.24. No abstract available.
- Background: PubMed 12650740Zimmermann U, Kraus T, Himmerich H, Schuld A, Pollmacher T. Epidemiology, implications and mechanisms underlying drug-induced weight gain in psychiatric patients. J Psychiatr Res. 2003 May-Jun;37(3):193-220. doi: 10.1016/s0022-3956(03)00018-9.
- Background: PubMed 7700379Tecott LH, Sun LM, Akana SF, Strack AM, Lowenstein DH, Dallman MF, Julius D. Eating disorder and epilepsy in mice lacking 5-HT2c serotonin receptors. Nature. 1995 Apr 6;374(6522):542-6. doi: 10.1038/374542a0.
- Background: PubMed 12629531Kroeze WK, Hufeisen SJ, Popadak BA, Renock SM, Steinberg S, Ernsberger P, Jayathilake K, Meltzer HY, Roth BL. H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs. Neuropsychopharmacology. 2003 Mar;28(3):519-26. doi: 10.1038/sj.npp.1300027.
- Derived from this study: PubMed 21808751Bobo WV, Epstein RA Jr, Shelton RC. Effects of orally disintegrating vs regular olanzapine tablets on body weight, eating behavior, glycemic and lipid indices, and gastrointestinal hormones: a randomized, open comparison in outpatients with bipolar depression. Ann Clin Psychiatry. 2011 Aug;23(3):193-201.
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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.
Richard C. Shelton, M.D. principal investigator
Vanderbilt University Medical Center
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 orally-disintegrating olanzapine and regular olanzapine in people with Bipolar Depression, run by Vanderbilt University 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 7 inclusion and 20 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 31 Jul 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 31 Jul 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?
Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8 (time frame: 10 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 NCT00384332, which also lists 11 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 31 Jul 2017.