Bipolar DepressionPhase 3NCT00868699

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

A Phase 3 study testing lurasidone in people with Bipolar Depression, run by Sumitomo Pharma America, Inc. at 55 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Bipolar Depression
What is being tested?: lurasidone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 505 participants
Where: 55 sitesin 8 countries
Study dates: Apr 2009to Feb 2012
Phase: Phase 3
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is diagnosed with bipolar I disorder, most resent episode depressed
Subject must have a lifetime history of at least one bipolar manic or mixed episode

Who cannot join

History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
Imminent risk of suicide or injury to self, others, or property

Trial locations and contacts

55 sites in 8 countries.

Country

City, postcode or hospital

55 sites in 8 countries

United States22 sites

Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209
Albuquerque, New Mexico, 87109
University of Colorado
Aurora, Colorado, 80045
FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200
Austin, Texas, 78756
Sheppard Pratt Health System,6501 North Charles Street
Baltimore, Maryland, 21285
Florida Clinical Research Center, LLC,3914 State Road 64 East
Bradenton, Florida, 34208
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Mood Disorders Program-UHCMC
Cleveland, Ohio, 44106
MetroHealth System
Cleveland, Ohio, 44122
Synergy Escondido,710 East Grand Ave.
Escondido, California, 92025
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
Garden Grove, California, 92645
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
Lake Charles, Louisiana, 70601
Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230
Maitland, Florida, 32751
American Medical Research Inc.,1200 Harger Road Suite 415
Oak Brook, Illinois, 60523
Excell Research, Inc,3998 Vista Way,Suite 100
Oceanside, California, 92056
University of California at Irvine Medical Center
Orange, California, 92868
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139
California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, 90660
Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125
Raleigh, North Carolina, 27609
Finger Lakes Clinical Research
Rochester, New York, 14618
California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor
San Diego, California, 92102
Depression and Anxiety Disorders Research Institute
Tampa, Florida, 33613
Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103
West Palm Beach, Florida, 33407

Other trials in United States

India9 sites

Samvedna Hospitals
Ahmedabad, Gujarat, 380006
Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, 380006
Mental Illness Treatment Rehabilitationi Foundation
Ahmedabad, Gujarat, 380013
Spandana Nursing Home
Bangalore, Karna, 560010
R.K. Yadav Memorial Mental Health & De-Addiction Hospital
Jaipur, Rajasthan, 302021
Manobal Med. Research Centre
Lucknow, Uttar Prad, 226006
Sujata Birla Hospital & Research Centre
Nashik, Mahara, 422101
S V Medical College
Tirupati, Andh Prad, 517507
Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
Vijaywada, Andh Prad, 520002

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Romania5 sites

Spitalul Clinic de Urgenta Militar Central
Bucdresti, 010825
Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
Bucharest, 041914
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, 400012
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova, 200620
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, 410154

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South Africa5 sites

Cape Trial Centre
Cape Town, W. Cape, 7530
Paarl Medical Centre
Paarl, W. Cape, 7646
Clinika
Port Elizabeth, E. Cape, 6000
Dey Clinic
Pretoria, Gauteng, 0181
Vereeniging Medi-Clinic
Vereeniging, Free State, 1941

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Ukraine5 sites

Chair of Psychiatry and Medical Psychology
Donetsk, Donetsk Oblast, 83008
Reg. Psychiatric Hospital
Odesa
Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B
Poltava, 36006
CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I
Simferopol, 95006
Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
Vinnitsia, 21018

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Czechia4 sites

Psychiatricka ambulance
Brno - Mesto, 602 00
Medical Services Prague s.r.o.
Kolejni 429-5, Prague
BIALBI s.r.o., Psychiatricke Oddeleni
Litoměřice
Clintrial, s.r.o.
Prague, 10 100 00

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Russia3 sites

City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
Saint Petersburg, 190121
Bekhterev Scientific Research Psychoneurological Institute
Saint Petersburg, 193019
Psychoneurology Dispensary #4
Saint Petersburg, 197110

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France2 sites

Hopital Caremeau, Service de Psychiatrie A
Nîmes, 30 30029
Zans Ritter, Marcel
Orvault, 44700

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About this study

Official title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

Conditions: Bipolar Depression
Being tested: lurasidone, Placebo
Keywords: Bipolar I, Depression
Medical subject headings: Bipolar Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lurasidoneDrug
lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
lurasidoneDrug
lurasidone 20 mg/day for Days 1-7
PlaceboDrug
Placebo Comparator

Study groups in NCT00868699
Study group	Role	What they receive
lurasidone low arm	Experimental	Not described Receives: Drug: lurasidone
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
lurasidone high arm	Experimental	Not described Receives: Drug: lurasidone

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.
The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
Measured: Baseline to Week 6

Secondary outcomes (2)

Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.
The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
Measured: Baseline to Week 6
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.
The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.
Measured: Baseline to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Feb 2012

First posted25 Mar 2009 (estimated)
Study startApr 2009
Primary completionFeb 2012
Study completionFeb 2012

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 (8)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 505 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00868699
Sponsor's protocol ID: D1050236
Other IDs: EUDRACT No. 2008-007457-13
Status last verified: Mar 2014
First submitted: 23 Mar 2009
Last updated: 17 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.
PubMed 24170180
Goldberg JF, Siu C, Tocco M, Pikalov A, Loebel A. The Effect of Lurasidone on Anxiety Symptoms in Patients With Bipolar Depression: A Post Hoc Analysis. J Clin Psychiatry. 2023 Jun 7;84(4):22m14732. doi: 10.4088/JCP.22m14732.
PubMed 37339360
Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10.
PubMed 30102967
Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.
PubMed 27529375
Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.
PubMed 27215976
Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.
PubMed 26730454
Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5.
PubMed 26363720
McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410.
PubMed 25844756

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
ClinicalTrials.gov ID: NCT00868699
Acronym / sponsor ID: D1050236
Conditions: Bipolar Depression
Keywords: Bipolar I, Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 505 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 25 Mar 2009 (estimated)
Results: Posted 2 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
lurasidone low arm	Experimental	Drug: lurasidone
Placebo	Placebo comparator	Drug: Placebo
lurasidone high arm	Experimental	Drug: lurasidone

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject is diagnosed with bipolar I disorder, most resent episode depressed
Subject must have a lifetime history of at least one bipolar manic or mixed episode

Key exclusion criteria (3 listed)

History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
Imminent risk of suicide or injury to self, others, or property

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
lurasidonelurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day	Drug	lurasidone high arm
lurasidonelurasidone 20 mg/day for Days 1-7	Drug	lurasidone low arm
PlaceboPlacebo Comparator	Drug	Placebo

Primary outcome

Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
Time frame: Baseline to Week 6
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.

2 secondary outcomes

Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Time frame: Baseline to Week 6
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Time frame: Baseline to Week 6

Results and safety

Results posted to the registry on 2 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	170	127
Lurasidone High Arm	169	124
Lurasidone Low Arm	166	123

Primary outcome: Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)

Time frame: Baseline to Week 6. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 162	Lurasidone High Arm n = 162	Lurasidone Low Arm n = 161
Value	-10.7 (0.83)	-15.4 (0.83)	-15.4 (0.83)

Placebo vs Lurasidone Low Arm: Mean Difference (Final Values): -4.6, p <0.001, Mixed Models Analysis
Placebo vs Lurasidone High Arm: Mean Difference (Final Values): -4.6, p <0.001, Mixed Models Analysis

Population analysed: Intent-to-treat population is analyzed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: April 29,2009 - February 1, 2012. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 168 (0.6%)	56 of 168 (33.3%)	Not reported
Lurasidone High Arm	5 of 167 (3%)	65 of 167 (38.9%)	Not reported
Lurasidone Low Arm	3 of 164 (1.8%)	57 of 164 (34.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24170180Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.
Derived from this study: PubMed 37339360Goldberg JF, Siu C, Tocco M, Pikalov A, Loebel A. The Effect of Lurasidone on Anxiety Symptoms in Patients With Bipolar Depression: A Post Hoc Analysis. J Clin Psychiatry. 2023 Jun 7;84(4):22m14732. doi: 10.4088/JCP.22m14732.
Derived from this study: PubMed 30102967Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10.
Derived from this study: PubMed 27529375Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.
Derived from this study: PubMed 27215976Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.
Derived from this study: PubMed 26730454Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.
Derived from this study: PubMed 26363720Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5.
Derived from this study: PubMed 25844756McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410.

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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.

Medical Director, MD study director

Sumitomo Pharma America, Inc.

55 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lurasidone in people with Bipolar Depression, run by Sumitomo Pharma America, Inc. at 55 sites in 8 countries.

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 2 inclusion and 3 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 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, India, Romania, South Africa, Ukraine and 3 more countries. 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?

Yes. Results are posted in the registry (first posted 2 Jul 2013). 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?

Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) (time frame: Baseline to Week 6). 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 NCT00868699, which also lists 8 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 17 Apr 2014.