SchizophreniaPhase 4NCT00492336

Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

A Phase 4 study testing rasagiline (Pharmacodynamics) in people with Schizophrenia, run by University of Maryland, Baltimore at 5 sites in United States.

Completed

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

Official record

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Trial summary

This is a study of a new medication for the treatment of cognitive impairments (thinking difficulties) and negative symptoms in people with schizophrenia. The new medication is rasagiline. Rasagiline is a drug which has been approved by the Food and Drug Administration for the treatment of Parkinson's disease. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Schizophrenia
What is being tested?: rasagiline (Pharmacodynamics)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 5 sitesUnited States
Study dates: Jan 2007to Feb 2012
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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
Current treatment with one or more second generation antipsychotics, except ziprasidone
On same second generation antipsychotic(s)for at least 56 days
On same dose of second generation antipsychotic(s)for at least 30 days
22-item SANS: Total score (i.e.all items minus global items and poverty of content of speech)greater than 20 or global Rating of Affective Flattening greater than or equal to 3 or global Rating of alogia greater than or equal to 3
BPRS: Sum of the four positive symptom items less than or equal to 16 (items 4,11,12,15)
BPRS: Sum of the four Anxiety/Depression Factor items less than or equal to 14 (items 1,2,5,9)
Simpson-Angus Scale: Total score less than or equal to 8

Who cannot join

DSM-IV Major Depressive Disorder within last 6 months
Current treatment with ziprasidone
DSM-IV diagnosis of alcohol or substance dependence within the last 6 months
DSM-IV criteria for alcohol or substance abuse within the last month
evidence of illicit substance use, as identified with urine toxicology screen
History of an organic brain disorder, mental retardation,epilepsy, or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol. See those listed below

Show all 11Show fewer

Uncontrolled hypertension defined as BP exceeding 145/90 on 3 consecutive readings despite adequate treatment, pheochromocytoma, melanoma, hepatic insufficiency
Pregnancy or lactation in females
Pheochromocytoma
Melanoma
Hepatic insufficiency

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Baltimore VA Medical Center
Baltimore, Maryland, 21201
Keypoint Mental health Center
Catonsville, Maryland, 21228
Maryland Psychiatric REsearch Center
Catonsville, Maryland, 21228
Mosaic Community Mental health Center
Catonsville, Maryland, 21228
Keypoint Mental health Center
Dundalk, Maryland, 21222

Other trials in United States

About this study

Read the detailed description

The study will consist of two phases: a 4-week continued stability phase (lead-in phase) and a 12-week double-blind treatment phase. In the lead-in phase, subjects receiving antipsychotic medication, who manifest moderate to severe and persistent negative symptoms, will remain on their maintenance regimen for at least four weeks. The treatment phase will be a 12-week, parallel groups, double-blind, placebo-controlled trial of adjunctive rasagiline (1 mg/day), a selective MAO-B oxidase inhibitor.

Conditions: Schizophrenia
Being tested: rasagiline (Pharmacodynamics), Placebo
Keywords: Cognitive impairments, Negative symptoms
Medical subject headings: Schizophrenia, Cognitive Dysfunction

What participants receive

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

rasagiline (Pharmacodynamics)Drug
Rasagiline 1 mg/day for 12 weeks
PlaceboDrug
Placebo 1 tablet each day

Study groups in NCT00492336
Study group	Role	What they receive
Rasagiline	Active comparator	Treatment with Rasagiline Receives: Drug: rasagiline (Pharmacodynamics)
Inactive pill	Placebo comparator	Treatment with Placebo Receives: Drug: Placebo

What is being measured

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

Change in Negative Symptoms
The Scale for the Assessment of Negative Symptoms (SANS) rating scale was used to assess the negative symptoms of schizophrenia. Scores on the subscales are combined (summed) to compute a total score. There are a total of 17 subscales. Each subscale ranges from 0="Not at all" to 5="Severe". Every 4 weeks the summed subscale scores provide a total score for that week (0-85). Higher scores indicate more severe negative symptoms.
Measured: Every 4 weeks over a 12 week period
Cognitive Testing - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score
The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.
Measured: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
Cognitive Testing - N-Back Neurocognitive Task
The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.
Measured: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
Cognitive Testing - Probabilistic Learning Task
To assess reward learning, participants used performance feedback to choose the most frequently rewarded item in each of three pairs of stimuli (one pair had reward probabilities: 80% vs 20%; one pair had reward probabilities of 70% vs 30%; one pair had the probabilities of 60% vs 40 %) (PL; Frank et al, 2004). A total of 240 trials were administered so each pair was seen 80 times. Higher scores represent more frequent choices of the optimal stimulus in each pair. The frequencies with which participants repeated an item choice that was rewarded on the previous presentation (win-stay) is also presented as a percentage. Similarly, the lose-shift score is the percentage of times that participants changed their choice for unrewarded items (lose-shift). The win-stay score serves as a measure of the impact of positive feedback on subsequent choices while the lost-shift score serves as a measure of the impact of negative feedback on subsequent choices.
Measured: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
Cognitive Testing - Delayed Discounting
The monetary choice questionnaire for hypothetical monetary rewards was used to assess delayed discounting (Kirby et al, 1999). The measure includes 27 items in which participants choose between a smaller, immediate reward (SIR) and a larger, delayed reward (LDR). There are three LDR sizes: small ($25-35), medium ($50-60) and large ($75-85). By examining the pattern of choices that participants make across the set of 27 items it is possible to calculate their delay discounting rate, termed K. The discount rate determines the steepness of the reduction in the present value of a reward with increases in the delay to the possible receipt of that reward. Thus, higher values in K represent greater discounting of the value of future rewards. With this measure K values can range between a low of 0.00016 to a high of 0.25. Higher K values have been linked to measures of impulsivity. Shown in the table are the K values observed when the future rewards were small, medium, or large.
Measured: Beginning of treatment phase (week 0) and end of treatment phase (week 12)

Secondary outcomes (6)

Extrapyramidal Symptoms
The Simpson Angus Scale (SAS; Simpson and Angus, 1970) was used to assess extrapyramidal symptoms (EPS). The assessment consists of 11 items, each rating the severity of potential symptoms of movement disorders. Total scores are calculated by summing the scores of each of the 11 items for a potential total score of 0-44, with higher scores indicating more severe EPS.
Measured: Baseline (Week 0) and End of Study (Week 12)
Number of Participants With Akathisia
The Barnes Akathisia Scale (BAS; Barnes, 1989) was used to assess akathisia, a type of extrapyramidal symptom. The global clinical assessment of akathisia score is rated on a scale from 0=Absent to 5=Severe Akathisia.
Measured: Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.
Change in Persistent Positive Symptoms
The Brief Psychiatric Rating Scale (BPRS) positive symptom item total score was used to assess positive symptom change. The BPRS positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating.
Measured: Every 4 weeks for 12 weeks.
Depressive Symptoms
The Calgary Depression Scale (CDS; Addington et al, 1997) total score was used to assess depressive symptoms over the course of the study. Total scores were calculated by summing the scores of each of the 9 items. Total scores can range from 0-27, with higher scores indicating more severe depressive symptoms.
Measured: Every 4 weeks for 12 weeks.
Global Change in Illness Severity
The Clinical Global Impression (CGI) severity of illness item was used to assess global changes. Scores on this item range from 1="Normal, not at all ill" to 7="Among the most extremely ill".
Measured: Every 4 weeks for 12 weeks.
Number of Participants Exhibiting Side Effects
The Side Effect Checklist (SEC) was used to assess side effects. The SEC is comprised of 22 common side effects, which are rated on a 1 (none)-4 (severe) scale. Side effects are determined to be clinically significant if there is a two or more point increase in severity from baseline, or any side effect that receives a severity rating of "4" (severe) at any point in the treatment phase of the study.
Measured: Every week for 12 weeks

Timeline

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

Jan 2007Feb 2012

First posted27 Jun 2007 (estimated)
Study startJan 2007
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 (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00492336
Sponsor's protocol ID: HP-00043807
Other IDs: H-27877
Status last verified: Jun 2013
First submitted: 26 Jun 2007
Last updated: 25 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Buchanan RW, Weiner E, Kelly DL, Gold JM, Keller WR, Waltz JA, McMahon RP, Gorelick DA. Rasagiline in the Treatment of the Persistent Negative Symptoms of Schizophrenia. Schizophr Bull. 2015 Jul;41(4):900-8. doi: 10.1093/schbul/sbu151. Epub 2014 Nov 2.
PubMed 25368372

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 Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
ClinicalTrials.gov ID: NCT00492336
Acronym / sponsor ID: HP-00043807
Conditions: Schizophrenia
Keywords: Cognitive impairments, Negative symptoms
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: Stanley Medical Research Institute
Study start: Jan 2007
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 27 Jun 2007 (estimated)
Results: Posted 19 Jun 2013

Clinical summary

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

Detailed description

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
Rasagiline	Active comparator	Drug: rasagiline (Pharmacodynamics)Treatment with Rasagiline
Inactive pill	Placebo comparator	Drug: PlaceboTreatment with Placebo

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
Current treatment with one or more second generation antipsychotics, except ziprasidone
On same second generation antipsychotic(s)for at least 56 days
On same dose of second generation antipsychotic(s)for at least 30 days
22-item SANS: Total score (i.e.all items minus global items and poverty of content of speech)greater than 20 or global Rating of Affective Flattening greater than or equal to 3 or global Rating of alogia greater than or equal to 3

Key exclusion criteria (11 listed)

DSM-IV Major Depressive Disorder within last 6 months
Current treatment with ziprasidone
DSM-IV diagnosis of alcohol or substance dependence within the last 6 months
DSM-IV criteria for alcohol or substance abuse within the last month
evidence of illicit substance use, as identified with urine toxicology screen

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
rasagiline (Pharmacodynamics)Rasagiline 1 mg/day for 12 weeks	Drug	Rasagiline
PlaceboPlacebo 1 tablet each day	Drug	Inactive pill

Primary outcome

Change in Negative Symptoms
Time frame: Every 4 weeks over a 12 week period
The Scale for the Assessment of Negative Symptoms (SANS) rating scale was used to assess the negative symptoms of schizophrenia. Scores on the subscales are combined (summed) to compute a total score. There are a total of 17 subscales. Each subscale ranges from 0="Not at all" to 5="Severe". Every 4 weeks the summed subscale scores provide a total score for that week (0-85). Higher scores indicate more severe negative symptoms.
Cognitive Testing - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score
Time frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.
Cognitive Testing - N-Back Neurocognitive Task
Time frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
The N-Back task is a sequential letter working memory task. D-prime was used to measure accuracy on the 0-back, 1-back, and 2-back conditions. D-prime scores range from 0 to 8.6. Higher scores are better. As memory load increases from 0 to 1, from 1 to 2, D-prime scores are expected to be lower.
Cognitive Testing - Probabilistic Learning Task
Time frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
To assess reward learning, participants used performance feedback to choose the most frequently rewarded item in each of three pairs of stimuli (one pair had reward probabilities: 80% vs 20%; one pair had reward probabilities of 70% vs 30%; one pair had the probabilities of 60% vs 40 %) (PL; Frank et al, 2004). A total of 240 trials were administered so each pair was seen 80 times. Higher scores represent more frequent choices of the optimal stimulus in each pair. The frequencies with which participants repeated an item choice that was rewarded on the previous presentation (win-stay) is also presented as a percentage. Similarly, the lose-shift score is the percentage of times that participants changed their choice for unrewarded items (lose-shift). The win-stay score serves as a measure of the impact of positive feedback on subsequent choices while the lost-shift score serves as a measure of the impact of negative feedback on subsequent choices.
Cognitive Testing - Delayed Discounting
Time frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
The monetary choice questionnaire for hypothetical monetary rewards was used to assess delayed discounting (Kirby et al, 1999). The measure includes 27 items in which participants choose between a smaller, immediate reward (SIR) and a larger, delayed reward (LDR). There are three LDR sizes: small ($25-35), medium ($50-60) and large ($75-85). By examining the pattern of choices that participants make across the set of 27 items it is possible to calculate their delay discounting rate, termed K. The discount rate determines the steepness of the reduction in the present value of a reward with increases in the delay to the possible receipt of that reward. Thus, higher values in K represent greater discounting of the value of future rewards. With this measure K values can range between a low of 0.00016 to a high of 0.25. Higher K values have been linked to measures of impulsivity. Shown in the table are the K values observed when the future rewards were small, medium, or large.

6 secondary outcomes

Extrapyramidal Symptoms
Time frame: Baseline (Week 0) and End of Study (Week 12)
Number of Participants With Akathisia
Time frame: Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.
Change in Persistent Positive Symptoms
Time frame: Every 4 weeks for 12 weeks.
Depressive Symptoms
Time frame: Every 4 weeks for 12 weeks.
Global Change in Illness Severity
Time frame: Every 4 weeks for 12 weeks.
Number of Participants Exhibiting Side Effects
Time frame: Every week for 12 weeks

Results and safety

Results posted to the registry on 19 Jun 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
Rasagiline	28	26
Inactive Pill	29	23

Primary outcome: Change in Negative Symptoms

Time frame: Every 4 weeks over a 12 week period. Mean (Standard Deviation). Unit: units on a scale

Measure	Rasagiline n = 26	Inactive Pill n = 28
Week 0	32.7 (8.5)	33.5 (7.8)
Week 4	31.2 (9.4)	32.3 (8.2)
Week 8	31.1 (8.1)	34.1 (8.6)
Week 12	29.9 (3.9)	34.3 (8.6)

Population analysed: Number of participants available for symptom efficacy analyses.

Primary outcome: Cognitive Testing - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score

Time frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12). Mean (Standard Deviation). Unit: units on a scale

Measure	Rasagiline n = 26	Inactive Pill n = 23
Week 0	76.8 (12.5)	74.2 (13.7)
Week 12	78.7 (14.1)	75.3 (14.5)
Change	1.9 (6.9)	1.1 (7.5)

Population analysed: Subjects completing the cognitive testing at both time points.

Primary outcome: Cognitive Testing - N-Back Neurocognitive Task

Time frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12). Mean (Standard Deviation). Unit: units on a scale

Measure	Rasagiline n = 26	Inactive Pill n = 23
0-Back: Week 0	3.47 (0.74)	3.52 (0.70)
0-Back: Week 12	3.79 (0.61)	3.66 (0.71)
0-Back: Change	0.32 (0.53)	0.14 (0.75)
1-Back: Week 0	2.75 (0.73)	2.63 (0.73)
1-Back: Week 12	2.96 (0.67)	2.66 (0.91)
1-Back: Change	0.20 (0.73)	0.03 (0.70)
2-Back: Week 0	1.75 (0.72)	1.56 (0.87)
2-Back: Week 12	1.59 (0.88)	1.57 (0.86)

Population analysed: Subjects completing the cognitive testing at both time points.

Primary outcome: Cognitive Testing - Probabilistic Learning Task

Time frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12). Mean (Standard Deviation). Unit: percentage of optimal stimuli chosen

Measure	Rasagiline n = 26	Inactive Pill n = 23
80 vs 20: Week 0	70.8 (23.7)	69.1 (25.1)
80 vs 20: Week 12	70.4 (24.5)	68.5 (25.8)
80 vs 20: Change	-0.4 (33.8)	-0.7 (36.8)
70 vs 30: Week 0	69.7 (22.3)	66.1 (19.8)
70 vs 30: Week 12	64.4 (23.4)	65.9 (18.8)
70 vs 30: Change	-5.3 (27.4)	-0.2 (25.6)
60 vs 40: Week 0	53.9 (26.9)	57.9 (24.9)
60 vs 40: Week 12	58.7 (23.8)	58.6 (18.2)

Population analysed: Subjects completing the cognitive testing at both time points. Results for lose shifts are calculated for 24 Rasagiline and 22 Placebo participants, due to missing data created by participants who had zero losses (and hence no need to shift) during both the 3rd and 4th blocks of trials.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the 12-week Treatment Phase of the study.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rasagiline	1 of 28 (3.6%)	1 of 28 (3.6%)	0 of 28
Inactive Pill	0 of 29 (0%)	3 of 29 (10.3%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25368372Buchanan RW, Weiner E, Kelly DL, Gold JM, Keller WR, Waltz JA, McMahon RP, Gorelick DA. Rasagiline in the Treatment of the Persistent Negative Symptoms of Schizophrenia. Schizophr Bull. 2015 Jul;41(4):900-8. doi: 10.1093/schbul/sbu151. Epub 2014 Nov 2.

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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.

Robert W Buchanan, M.D. principal investigator

University of Maryland, College Park

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rasagiline (Pharmacodynamics) in people with Schizophrenia, run by University of Maryland, Baltimore at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 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 19 Jun 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?

Change in Negative Symptoms (time frame: Every 4 weeks over a 12 week period). The study lists 5 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 NCT00492336, 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 25 Sep 2019.