A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

A Phase 3 study testing ALKS 9072 in people with Schizophrenia, run by Alkermes, Inc. at 84 sites in 8 countries.

Completed

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

Trial summary

The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Schizophrenia
What is being tested?: ALKS 9072
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 623 participants
Where: 84 sitesin 8 countries
Study dates: Dec 2011to Mar 2014
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of schizophrenia according to DSM-IV-TR criteria
Has been able to achieve outpatient status for more than 3 months in the past year
Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
Resides in a stable living situation
Willing and able to be confined to an inpatient study unit for 2 weeks or longer

Who cannot join

History of poor or inadequate clinical response to treatment with aripiprazole
History of treatment resistance
Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
Diagnosis of current substance dependence (including alcohol)
Pregnant, lactating, or breastfeeding
Receipt of any antipsychotic medication by IM injection within 60 days before Screening

Show all 9Show fewer

Current involuntary hospitalization or incarceration
Hospitalized for more than 30 days during the 90 days before Screening
Additional inclusion/exclusion criteria may apply.

Trial locations and contacts

84 sites in 8 countries.

Country

City, postcode or hospital

84 sites in 8 countries

United States26 sites

Alkermes Investigational Site
Atlanta, Georgia, 30308
Alkermes Investigational Site
Austin, Texas, 78731
Alkermes Investigational Site
Austin, Texas, 78754
Alkermes Investigational Site
Cerritos, California, 90703
Alkermes Investigational Site
Charleston, South Carolina, 29407
Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Creve Coeur, Missouri, 63141
Alkermes Investigational Site
Dallas, Texas, 75231
Alkermes Investigational Site
Dallas, Texas, 75243
Alkermes Investigational Site
Fort Lauderdale, Florida, 33308
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Hoffman Estates, Illinois, 60169
Alkermes Investigational Site
La Habra, California, 90631
Alkermes Investigational site
Leesburg, Florida, 34748
Alkermes Investigational Site
Little Rock, Arkansas, 72201
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Oakland, California, 94612
Alkermes Investigational Site
Oceanside, California, 92056
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
Overland Park, Kansas, 66212
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19139
Alkermes Investigational Site
Rockville, Maryland, 20850
Alkermes Investigational Site
San Diego, California, 92123
Alkermes Investigational Site
Springdale, Arkansas, 72764
Alkermes Investigational Site
St Louis, Missouri, 63118
Alkermes Investigational Site
Washington D.C., District of Columbia, 20016

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Russia14 sites

Alkermes Investigational Site
Khot'kovo, Sergievo-Posadskiy
Alkermes Investigational Site
Lipetsk
Alkermes Investigational Site
Moscow
Alkermes Investigational Site
Nikol’skoye, Gatchinckiy
Alkermes Investigational Site
Nizhny Novgorod
Alkermes Investigational Site
Rostov-on-Don
Alkermes Investigational Site
Saint Petersburg
Alkermes Investigational Site
Samara
Alkermes Investigational Site
Saratov
Alkermes Investigational Site
Staritsa, Orenburg Oblast
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Stavropol
Alkermes Investigational Site
Talagi, Primorskiy (Maritime) Kray
Alkermes Investigational Site
Voronezh
Alkermes Investigational Site
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Bulgaria13 sites

Alkermes Investigational Site
Burgas
Alkermes Investigational Site
Kazanlak
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Alkermes Investigational Site
Pazardzhik
Alkermes Investigational Site
Pleven
Alkermes Investigational Site
Plovdiv
Alkermes Investigational Site
Radnevo
Alkermes Investigational Site
Rousse
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Sofia
Alkermes Investigational Site
Stara Zagora
Alkermes Investigational Site
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Alkermes Investigational Site
Veliko Tarnovo
Alkermes Investigational Site
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Ukraine12 sites

Alkermes Investigational Site
Chernihiv
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Donetsk
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Kharkiv
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Kyiv
Alkermes Investigational Site
Luhansk
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Lviv
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Poltava
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Simferopol
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Philippines6 sites

Alkermes Investigational Site
Cebu City
Alkermes Investigational Site
Iloilo City
Alkermes Investigational Site
Mandaluyong
Alkermes Investigational Site
Manila
Alkermes Investigational Site
Mariveles, Bataan
Alkermes Investigational Site
Pasig

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Romania6 sites

Alkermes Investigational Site
Bucharest, 030455
Alkermes Investigational Site
Bucharest
Alkermes Investigational Site
Craiova
Alkermes Investigational Site
Iași
Alkermes Investigational Site
Oradea, Bihor County
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Malaysia4 sites

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Johor Bahru
Alkermes Investigational Site
Kuala Lumpur
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South Korea3 sites

Alkermes Investigational Site
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About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia

The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.

Conditions: Schizophrenia
Being tested: ALKS 9072, Placebo
Keywords: Alkermes, schizophrenia, ALKS 9072, ALKS 9070, aripiprazole lauroxil
Medical subject headings: Schizophrenia

What participants receive

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

ALKS 9072Drug
Intramuscular (IM) injection, 441 mg or 882 mg given monthly
PlaceboDrug
Placebo for IM injection, given monthly

Study groups in NCT01469039
Study group	Role	What they receive
ALKS 9072	Experimental	Not described Receives: Drug: ALKS 9072
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.
Measured: Data collected from baseline to day 85

Secondary outcomes (1)

Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: "1: very much improved"; "2: much improved"; "3: minimally improved"; "4: no change"; "5: minimally worse"; "6: much worse"; or "7: very much worse".
Measured: 85 Days

Timeline

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

Dec 2011Mar 2014

First posted10 Nov 2011 (estimated)
Study startDec 2011
Primary completionJan 2014
Study completionMar 2014

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 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: 623 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01469039
Sponsor's protocol ID: ALK9072-003
Status last verified: Jan 2019
First submitted: 8 Nov 2011
Last updated: 30 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Targum SD, Risinger R, Du Y, Pendergrass JC, Jamal HH, Silverman BL. Effect of patient age on treatment response in a study of the acute exacerbation of psychosis in schizophrenia. Schizophr Res. 2017 Jan;179:64-69. doi: 10.1016/j.schres.2016.09.034. Epub 2016 Oct 1.
PubMed 27707530
Nasrallah HA, Newcomer JW, Risinger R, Du Y, Zummo J, Bose A, Stankovic S, Silverman BL, Ehrich EW. Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia. J Clin Psychiatry. 2016 Nov;77(11):1519-1525. doi: 10.4088/JCP.15m10467.
PubMed 27574838
Citrome L, Du Y, Risinger R, Stankovic S, Claxton A, Zummo J, Bose A, Silverman BL, Ehrich EW. Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia. Int Clin Psychopharmacol. 2016 Mar;31(2):69-75. doi: 10.1097/YIC.0000000000000106.
PubMed 26517202
Meltzer HY, Risinger R, Nasrallah HA, Du Y, Zummo J, Corey L, Bose A, Stankovic S, Silverman BL, Ehrich EW. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015 Aug;76(8):1085-90. doi: 10.4088/JCP.14m09741.
PubMed 26114240
Potkin SG, Risinger R, Du Y, Zummo J, Bose A, Silverman B, Stankovic S, Ehrich E. Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation. Schizophr Res. 2017 Dec;190:115-120. doi: 10.1016/j.schres.2017.03.003. Epub 2017 Mar 23.
PubMed 28342578
Cameron C, Zummo J, Desai DN, Drake C, Hutton B, Kotb A, Weiden PJ. Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison. Value Health. 2017 Jul-Aug;20(7):876-885. doi: 10.1016/j.jval.2017.03.010. Epub 2017 May 9.
PubMed 28712616
Citrome L, Risinger R, Cutler AJ, Du Y, Zummo J, Nasrallah HA, Silverman BL. Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study. CNS Spectr. 2018 Aug;23(4):284-290. doi: 10.1017/S1092852917000396. Epub 2017 Jun 19.
PubMed 28625204
Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.
PubMed 28350572
Cameron C, Zummo J, Desai D, Drake C, Hutton B, Kotb A, Weiden PJ. Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies. Curr Med Res Opin. 2018 Apr;34(4):725-733. doi: 10.1080/03007995.2017.1410471. Epub 2018 Jan 10.
PubMed 29179595
Sommi RW, Saklad SR, Weiden PJ, Still D, Wang M, Yagoda S. Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens. J Clin Psychiatry. 2024 Aug 12;85(3):23m15132. doi: 10.4088/JCP.23m15132.
PubMed 39145678
McEvoy JP, Risinger R, Mykhnyak S, Du Y, Liu CC, Stanford AD, Weiden PJ. Durability of Therapeutic Response With Long-Term Aripiprazole Lauroxil Treatment Following Successful Resolution of an Acute Episode of Schizophrenia. J Clin Psychiatry. 2017 Sep-Oct;78(8):1103-1109. doi: 10.4088/JCP.17m11625.
PubMed 28937706

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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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia
ClinicalTrials.gov ID: NCT01469039
Acronym / sponsor ID: ALK9072-003
Conditions: Schizophrenia
Keywords: Alkermes, schizophrenia, ALKS 9072, ALKS 9070, aripiprazole lauroxil
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 623 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jan 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 10 Nov 2011 (estimated)
Results: Posted 22 Jan 2016

Clinical summary

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

The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.

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
ALKS 9072	Experimental	Drug: ALKS 9072
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of schizophrenia according to DSM-IV-TR criteria
Has been able to achieve outpatient status for more than 3 months in the past year
Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
Resides in a stable living situation
Willing and able to be confined to an inpatient study unit for 2 weeks or longer

Key exclusion criteria (9 listed)

History of poor or inadequate clinical response to treatment with aripiprazole
History of treatment resistance
Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
Diagnosis of current substance dependence (including alcohol)
Pregnant, lactating, or breastfeeding

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
ALKS 9072Intramuscular (IM) injection, 441 mg or 882 mg given monthly	Drug	ALKS 9072
PlaceboPlacebo for IM injection, given monthly	Drug	Placebo

Primary outcome

The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Data collected from baseline to day 85
The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.

1 secondary outcome

Clinical Global Impression - Improvement (CGI-I) Scores at Day 85
Time frame: 85 Days

Results and safety

Results posted to the registry on 22 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole Lauroxil 441 mg	207	130
Aripiprazole Lauroxil 882 mg	208	135
Placebo	208	95

Primary outcome: The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score

Time frame: Data collected from baseline to day 85. Least squares mean (Standard Error). Unit: units on a scale

Measure	Aripiprazole Lauroxil 441 mg n = 196	Aripiprazole Lauroxil 882 mg n = 204	Placebo n = 196
Value	-20.9 (1.39)	-21.8 (1.35)	-9.8 (1.39)

Aripiprazole Lauroxil 441 mg: p <0.001, ANCOVA
Aripiprazole Lauroxil 882 mg: p <0.001, ANCOVA

Population analysed: Full Analysis Set (FAS) defined as all randomized subjects who received at least 1 dose of IM study drug and had at least 1 primary efficacy assessment after administration of IM study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected during the 85-day treatment period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole Lauroxil 441 mg	3 of 207 (1.4%)	66 of 207 (31.9%)	Not reported
Aripiprazole Lauroxil 882 mg	4 of 208 (1.9%)	68 of 208 (32.7%)	Not reported
Placebo	4 of 207 (1.9%)	76 of 207 (36.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27707530Targum SD, Risinger R, Du Y, Pendergrass JC, Jamal HH, Silverman BL. Effect of patient age on treatment response in a study of the acute exacerbation of psychosis in schizophrenia. Schizophr Res. 2017 Jan;179:64-69. doi: 10.1016/j.schres.2016.09.034. Epub 2016 Oct 1.
Results publication: PubMed 27574838Nasrallah HA, Newcomer JW, Risinger R, Du Y, Zummo J, Bose A, Stankovic S, Silverman BL, Ehrich EW. Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia. J Clin Psychiatry. 2016 Nov;77(11):1519-1525. doi: 10.4088/JCP.15m10467.
Results publication: PubMed 26517202Citrome L, Du Y, Risinger R, Stankovic S, Claxton A, Zummo J, Bose A, Silverman BL, Ehrich EW. Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia. Int Clin Psychopharmacol. 2016 Mar;31(2):69-75. doi: 10.1097/YIC.0000000000000106.
Results publication: PubMed 26114240Meltzer HY, Risinger R, Nasrallah HA, Du Y, Zummo J, Corey L, Bose A, Stankovic S, Silverman BL, Ehrich EW. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015 Aug;76(8):1085-90. doi: 10.4088/JCP.14m09741.
Results publication: PubMed 28342578Potkin SG, Risinger R, Du Y, Zummo J, Bose A, Silverman B, Stankovic S, Ehrich E. Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation. Schizophr Res. 2017 Dec;190:115-120. doi: 10.1016/j.schres.2017.03.003. Epub 2017 Mar 23.
Results publication: PubMed 28712616Cameron C, Zummo J, Desai DN, Drake C, Hutton B, Kotb A, Weiden PJ. Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison. Value Health. 2017 Jul-Aug;20(7):876-885. doi: 10.1016/j.jval.2017.03.010. Epub 2017 May 9.
Results publication: PubMed 28625204Citrome L, Risinger R, Cutler AJ, Du Y, Zummo J, Nasrallah HA, Silverman BL. Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study. CNS Spectr. 2018 Aug;23(4):284-290. doi: 10.1017/S1092852917000396. Epub 2017 Jun 19.
Results publication: PubMed 28350572Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.
Results publication: PubMed 29179595Cameron C, Zummo J, Desai D, Drake C, Hutton B, Kotb A, Weiden PJ. Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies. Curr Med Res Opin. 2018 Apr;34(4):725-733. doi: 10.1080/03007995.2017.1410471. Epub 2018 Jan 10.
Derived from this study: PubMed 39145678Sommi RW, Saklad SR, Weiden PJ, Still D, Wang M, Yagoda S. Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens. J Clin Psychiatry. 2024 Aug 12;85(3):23m15132. doi: 10.4088/JCP.23m15132.
Derived from this study: PubMed 28937706McEvoy JP, Risinger R, Mykhnyak S, Du Y, Liu CC, Stanford AD, Weiden PJ. Durability of Therapeutic Response With Long-Term Aripiprazole Lauroxil Treatment Following Successful Resolution of an Acute Episode of Schizophrenia. J Clin Psychiatry. 2017 Sep-Oct;78(8):1103-1109. doi: 10.4088/JCP.17m11625.
Russian clinical trials websiteLink provided by the sponsor.
EU Clinical Trials Register; EudraCT number 2012-003445-15Link provided by the sponsor.

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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.

Alkermes Medical Director study director

Alkermes, Inc.

84 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 ALKS 9072 in people with Schizophrenia, run by Alkermes, Inc. at 84 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 5 inclusion and 9 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Russia, Bulgaria, Ukraine, Philippines 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 22 Jan 2016). 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?

The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: Data collected from baseline to day 85). 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 NCT01469039, 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 30 Jan 2019.