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Generalized Anxiety DisorderPhase 3NCT00734071

An Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

A Phase 3 study testing Vortioxetine in people with Generalized Anxiety Disorder, run by Takeda at 33 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

The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Generalized Anxiety Disorder
What is being tested?
Vortioxetine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
304 participants
Where
33 sitesUnited States
Study dates
Jun 2008to Mar 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria.
  • Has a Hamilton Anxiety Scale total score greater than or equal to 20 at Screening and Baseline.
  • Has a Hamilton Anxiety Scale score greater than or equal to 2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
  • Has a Montgomery-Åsberg Depression Rating Scale total score less than or equal to 16 at Screening and Baseline.

Who cannot join

  • Has 1 or more of the following:
  • Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview [MINI]).
  • Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
  • Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR® and subject must have a negative urine drug screen prior to Baseline.
  • Presence or history of a clinically significant neurological disorder (including epilepsy).
  • Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc.).
Show all 18Show fewer
  • Any Axis II disorder that might compromise the study.
  • Is taking excluded medications.
  • Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on Item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
  • Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
  • Has received electroconvulsive therapy within 6 months prior to Screening.
  • Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
  • Has a clinically significant unstable illness.
  • Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level greater than 1.5 times the upper limit of normal.
  • Has a serum creatinine of greater than 1.5 times the upper limit of normal.
  • Has a previous history of cancer that had been in remission for less than 5 years.
  • Has thyroid stimulating hormone value outside the normal range at Screening and is deemed clinically significant by the investigator.
  • Has an abnormal electrocardiogram.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Study site

    Anaheim, California

  • Study site

    Arcadia, California

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Bradenton, Florida

  • Study site

    Brooklyn, New York

  • Study site

    Charleston, West Virginia

  • Study site

    Cincinnati, Ohio

  • Study site

    Coral Gables, Florida

  • Study site

    Fall River, Massachusetts

  • Study site

    Flowood, Mississippi

  • Study site

    Irvine, California

  • Study site

    Lafayette, Indiana

  • Study site

    Lincoln, Rhode Island

  • Study site

    Memphis, Tennessee

  • Study site

    Morganton, North Carolina

  • Study site

    National City, California

  • Study site

    New York, New York

  • Study site

    North Miami, Florida

  • Study site

    Oak Brook, Illinois

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Park Ridge, Illinois

  • Study site

    Portland, Oregon

  • Study site

    San Antonio, Texas

  • Study site

    Sherman Oaks, California

  • Study site

    St. Petersburg, Florida

  • Study site

    Tampa, Florida

  • Study site

    The Bronx, New York

  • Study site

    Toledo, Ohio

  • Study site

    Upland, California

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wichita, Kansas

  • Study site

    Worcester, Massachusetts

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of Single Dose of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder

The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.

Read the detailed description

The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine.

The study enrolled 304 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

  • Vortioxetine 5 mg
  • Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 13 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Being tested
Vortioxetine, Placebo
Keywords
Generalized Anxiety Disorder, Mood Disorder, Affective Disorder, Anxiety Disorder, Drug Therapy
Medical subject headings
Generalized Anxiety Disorder, Mood Disorders, Anxiety Disorders

What participants receive

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

  • VortioxetineDrug

    Also called Lu AA21004, Brintellix®

    Encapsulated vortioxetine immediate-release tablets

  • PlaceboDrug

    Vortioxetine placebo-matching capsules

Study groups in NCT00734071
Study groupRoleWhat they receive
PlaceboPlacebo comparatorVortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Receives: Drug: Placebo
Vortioxetine 5 mgExperimentalVortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Receives: Drug: Vortioxetine

What is being measured

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

  1. Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8

    The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Week 8

Secondary outcomes (24)

  1. Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8

    The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Week 8

  2. Clinical Global Impression Scale-Global Improvement at Week 8

    The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Week 8

  3. Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8

    The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Week 8

  4. Percentage of Responders in HAM-A Total Score at Week 8

    Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).

    Measured: Baseline and Week 8

  5. Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25

    The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Week 8

  6. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8

    The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Week 8

  7. Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed

    The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 1, 2, 4 and 6.

  8. Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed

    The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 1 and 4

  9. Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed

    The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 1, 2, 4 and 6

  10. Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed

    The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means and P-values were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 1, 2 and 4

  11. Percentage of Responders in HAM-A Total Score at Other Weeks Assessed

    Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).

    Measured: Baseline and Weeks 1, 2, 4 and 6

  12. Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25

    The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 1, 2, 4 and 6

  13. Percentage of Participants in HAM-A Remission at Each Week Assessed

    Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).

    Measured: Weeks 1, 2, 4, 6 and 8

  14. Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed

    The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 1, 2, 4, 6 and 8

  15. Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed

    The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 1, 4 and 8

  16. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed

    The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 2 and 4

  17. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed

    The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 2, 4 and 8

  18. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed

    The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 2, 4 and 8

  19. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed

    The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 2, 4 and 8

  20. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed

    The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 2, 4 and 8

  21. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed

    The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 2, 4 and 8

  22. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed

    The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 2, 4 and 8

  23. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed

    The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).

    Measured: Baseline to Weeks 2, 4 and 8

  24. Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire

    Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.

    Measured: Baseline and Week 8

Timeline

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

  1. First posted13 Aug 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2009
  4. Study completionMar 2009

Resources

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
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00734071
Sponsor's protocol ID
LuAA21004_310
Other IDs
U1111-1114-4876
Status last verified
Oct 2013
First submitted
11 Aug 2008
Last updated
18 Dec 2013
Data monitoring committee
No

Publications

  • Rothschild AJ, Mahableshwarkar AR, Jacobsen P, Yan M, Sheehan DV. Vortioxetine (Lu AA21004) 5 mg in generalized anxiety disorder: results of an 8-week randomized, double-blind, placebo-controlled clinical trial in the United States. Eur Neuropsychopharmacol. 2012 Dec;22(12):858-66. doi: 10.1016/j.euroneuro.2012.07.011. Epub 2012 Aug 15.

    PubMed 22901736

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vortioxetine in people with Generalized Anxiety Disorder, run by Takeda at 33 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 4 inclusion and 18 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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 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 18 Dec 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 From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 (time frame: Baseline to Week 8). 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 NCT00734071, 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 18 Dec 2013.

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