SchizophreniaPhase 4NCT00595504
Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
A Phase 4 study testing Ramelteon in people with Schizophrenia and Schizoaffective Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study involves people who have schizophrenia or schizoaffective disorder who are currently taking antipsychotic medications. Some antipsychotic medications may cause weight gain and may increase the risk of diabetes mellitus and heart disease.The purpose of this study is to find out what happens if another… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- What is being tested?
- Ramelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder
- male or female, age 18-65 years
- treatment with clozapine, olanzapine, quetiapine or risperidone
- well established compliance with medications
- Body Mass Index (BMI) of > 27 Kg/m² with any component of metabolic syndrome or insulin resistance or a BMI of > 30 Kg/m²:
Who cannot join
- inability to provide informed consent
- substance and alcohol abuse
- significant medical illness, including congestive heart failure, severe hepatic impairment, severe Chronic Obstructive Pulmonary Disease (COPD), severe sleep apnea, severe cardiovascular disease or renal disease
- current history of diabetes mellitus or thyroid disease
- women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
- psychiatrically unstable, patients with major depression
Show all 12Show fewer
- patients treated with medications known to affect glucose tolerance such as birth control pills containing norgestrel, steroids, beta blockers, anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; and agents that induce weight loss will be excluded from the study
- treatment with fluvoxamine in the or ketoconazole past two weeks
- treatment with fluconazole (a strong CYP2C9 inhibitor).
- subjects treated with ziprasidone and aripiprazole conventional agents
- treatment with sedative-hypnotics such as barbiturates, zolpidem, eszopiclone, zaleplon. The use of stable daily doses of benzodiazepines is allowed.
- known hypersensitivity to ramelteon or any of its components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
This study involves people who have schizophrenia or schizoaffective disorder who are currently taking antipsychotic medications. Some antipsychotic medications may cause weight gain and may increase the risk of diabetes mellitus and heart disease.The purpose of this study is to find out what happens if another medication (ramelteon) is used along with your antipsychotic medication. We want to find out whether doing this will:
- Change the way your body breaks down fat and sugar.
- Affect your waist size, stomach fat and triglycerides (a type of fat in your blood).
- Improve how your body responds to insulin.
- Affect your quality of sleep.
- Reduce movement disturbances Ramelteon is approved by the U.S. Food and Drug Administration (FDA) to treat people that have difficulty falling asleep. It is not approved for such things as affecting waist size or improving how the body breaks down fat and sugar. Its use in this study is investigational.
Read the detailed description
This is an 8-week randomized, double blind, placebo-controlled pilot study with 4- week follow up assessment, of ramelteon 8 mg/day, administered to subjects for 8 consecutive weeks as an adjunctive therapy in 40 non-diabetic schizophrenia subjects to examine ramelteon effects on body composition, glucose and lipid metabolism, sleep quality and symptoms of tardive dyskinesia using the Massachusetts General Hospital General Clinical Research Center. As far as we know, no previous study has been done to explore the potential role of ramelteon in improving metabolic, sleep, and movement disturbances in schizophrenia subjects. The novel approach of adjunctive ramelteon treatment in the schizophrenia population is promising.
- Being tested
- Ramelteon, Placebo
- Keywords
- schizophrenia, metabolism, antipsychotics, diabetes, rozerem
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
Also called Rozerem
Two week supply of ramelteon 8mg/day first dispensed at baseline. New two week supply of study medication dispensed at each biweekly visit for 8 consecutive weeks.
PlaceboDrug
Two week supply of placebo tablets first dispensed at baseline. New two week supply of placebo dispensed at each biweekly visit for 8 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ramelteon 8mg/day Receives: Drug: Ramelteon |
| 2 | Placebo comparator | sugar pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Waist Circumference
A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.
Measured: Baseline and Week 8
Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8.
Measured: Baseline and Week 8
Change in Abdominal Fat (DEXA).
A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.
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.
- First posted16 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (62)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, David C. Henderson, Massachusetts General Hospital
- Investigators
- David C. Henderson, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595504
- Sponsor's protocol ID
- 2007P-001929
- Other IDs
- FWA00003136
- Status last verified
- Aug 2012
- First submitted
- 7 Jan 2008
- Last updated
- 13 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ananth J, Venkatesh R, Burgoyne K, Gadasalli R, Binford R, Gunatilake S. Atypical antipsychotic induced weight gain: pathophysiology and management. Ann Clin Psychiatry. 2004 Apr-Jun;16(2):75-85. doi: 10.1080/10401230490453293.
PubMed 15328901Henderson DC. Schizophrenia and comorbid metabolic disorders. J Clin Psychiatry. 2005;66 Suppl 6:11-20.
PubMed 16107179Henderson DC. Atypical antipsychotic-induced diabetes mellitus: how strong is the evidence? CNS Drugs. 2002;16(2):77-89. doi: 10.2165/00023210-200216020-00001.
PubMed 11825099Henderson DC, Copeland PM, Borba CP, Daley TB, Nguyen DD, Cagliero E, Evins AE, Zhang H, Hayden DL, Freudenreich O, Cather C, Schoenfeld DA, Goff DC. Glucose metabolism in patients with schizophrenia treated with olanzapine or quetiapine: a frequently sampled intravenous glucose tolerance test and minimal model analysis. J Clin Psychiatry. 2006 May;67(5):789-97. doi: 10.4088/jcp.v67n0513.
PubMed 16841629Casey DE, Haupt DW, Newcomer JW, Henderson DC, Sernyak MJ, Davidson M, Lindenmayer JP, Manoukian SV, Banerji MA, Lebovitz HE, Hennekens CH. Antipsychotic-induced weight gain and metabolic abnormalities: implications for increased mortality in patients with schizophrenia. J Clin Psychiatry. 2004;65 Suppl 7:4-18; quiz 19-20. No abstract available.
PubMed 15151456Allison DB, Mentore JL, Heo M, Chandler LP, Cappelleri JC, Infante MC, Weiden PJ. Antipsychotic-induced weight gain: a comprehensive research synthesis. Am J Psychiatry. 1999 Nov;156(11):1686-96. doi: 10.1176/ajp.156.11.1686.
PubMed 10553730Newcomer JW, Haupt DW, Fucetola R, Melson AK, Schweiger JA, Cooper BP, Selke G. Abnormalities in glucose regulation during antipsychotic treatment of schizophrenia. Arch Gen Psychiatry. 2002 Apr;59(4):337-45. doi: 10.1001/archpsyc.59.4.337.
PubMed 11926934Henderson DC, Cagliero E, Copeland PM, Borba CP, Evins AE, Hayden D, Weber MT, Anderson EJ, Allison DB, Daley TB, Schoenfeld D, Goff DC. Glucose metabolism in patients with schizophrenia treated with atypical antipsychotic agents: a frequently sampled intravenous glucose tolerance test and minimal model analysis. Arch Gen Psychiatry. 2005 Jan;62(1):19-28. doi: 10.1001/archpsyc.62.1.19.
PubMed 15630069Bonora E, Kiechl S, Willeit J, Oberhollenzer F, Egger G, Targher G, Alberiche M, Bonadonna RC, Muggeo M. Prevalence of insulin resistance in metabolic disorders: the Bruneck Study. Diabetes. 1998 Oct;47(10):1643-9. doi: 10.2337/diabetes.47.10.1643.
PubMed 9753305Kitabchi AE, Temprosa M, Knowler WC, Kahn SE, Fowler SE, Haffner SM, Andres R, Saudek C, Edelstein SL, Arakaki R, Murphy MB, Shamoon H; Diabetes Prevention Program Research Group. Role of insulin secretion and sensitivity in the evolution of type 2 diabetes in the diabetes prevention program: effects of lifestyle intervention and metformin. Diabetes. 2005 Aug;54(8):2404-14. doi: 10.2337/diabetes.54.8.2404.
PubMed 16046308Lillioja S, Mott DM, Spraul M, Ferraro R, Foley JE, Ravussin E, Knowler WC, Bennett PH, Bogardus C. Insulin resistance and insulin secretory dysfunction as precursors of non-insulin-dependent diabetes mellitus. Prospective studies of Pima Indians. N Engl J Med. 1993 Dec 30;329(27):1988-92. doi: 10.1056/NEJM199312303292703.
PubMed 8247074Semenkovich CF. Insulin resistance and atherosclerosis. J Clin Invest. 2006 Jul;116(7):1813-22. doi: 10.1172/JCI29024.
PubMed 16823479Weyer C, Tataranni PA, Bogardus C, Pratley RE. Insulin resistance and insulin secretory dysfunction are independent predictors of worsening of glucose tolerance during each stage of type 2 diabetes development. Diabetes Care. 2001 Jan;24(1):89-94. doi: 10.2337/diacare.24.1.89.
PubMed 11194248Carr DB, Utzschneider KM, Hull RL, Kodama K, Retzlaff BM, Brunzell JD, Shofer JB, Fish BE, Knopp RH, Kahn SE. Intra-abdominal fat is a major determinant of the National Cholesterol Education Program Adult Treatment Panel III criteria for the metabolic syndrome. Diabetes. 2004 Aug;53(8):2087-94. doi: 10.2337/diabetes.53.8.2087.
PubMed 15277390Hayashi T, Boyko EJ, Leonetti DL, McNeely MJ, Newell-Morris L, Kahn SE, Fujimoto WY. Visceral adiposity and the risk of impaired glucose tolerance: a prospective study among Japanese Americans. Diabetes Care. 2003 Mar;26(3):650-5. doi: 10.2337/diacare.26.3.650.
PubMed 12610016
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00595504
- Acronym / sponsor ID
- 2007P-001929
- Keywords
- schizophrenia, metabolism, antipsychotics, diabetes, rozerem
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Jan 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 13 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves people who have schizophrenia or schizoaffective disorder who are currently taking antipsychotic medications. Some antipsychotic medications may cause weight gain and may increase the risk of diabetes mellitus and heart disease.The purpose of this study is to find out what happens if another medication (ramelteon) is used along with your antipsychotic medication. We want to find out whether doing this will:
- Change the way your body breaks down fat and sugar.
- Affect your waist size, stomach fat and triglycerides (a type of fat in your blood).
- Improve how your body responds to insulin.
- Affect your quality of sleep.
- Reduce movement disturbances Ramelteon is approved by the U.S. Food and Drug Administration (FDA) to treat people that have difficulty falling asleep. It is not approved for such things as affecting waist size or improving how the body breaks down fat and sugar. Its use in this study is investigational.
Detailed description
This is an 8-week randomized, double blind, placebo-controlled pilot study with 4- week follow up assessment, of ramelteon 8 mg/day, administered to subjects for 8 consecutive weeks as an adjunctive therapy in 40 non-diabetic schizophrenia subjects to examine ramelteon effects on body composition, glucose and lipid metabolism, sleep quality and symptoms of tardive dyskinesia using the Massachusetts General Hospital General Clinical Research Center. As far as we know, no previous study has been done to explore the potential role of ramelteon in improving metabolic, sleep, and movement disturbances in schizophrenia subjects. The novel approach of adjunctive ramelteon treatment in the schizophrenia population is promising.
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 |
|---|---|---|
| 1 | Experimental | Drug: RamelteonRamelteon 8mg/day |
| 2 | Placebo comparator | Drug: Placebosugar pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder
- male or female, age 18-65 years
- treatment with clozapine, olanzapine, quetiapine or risperidone
- well established compliance with medications
- Body Mass Index (BMI) of > 27 Kg/m² with any component of metabolic syndrome or insulin resistance or a BMI of > 30 Kg/m²:
Key exclusion criteria (12 listed)
- inability to provide informed consent
- substance and alcohol abuse
- significant medical illness, including congestive heart failure, severe hepatic impairment, severe Chronic Obstructive Pulmonary Disease (COPD), severe sleep apnea, severe cardiovascular disease or renal disease
- current history of diabetes mellitus or thyroid disease
- women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
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 |
|---|---|---|
| RamelteonAlso: RozeremTwo week supply of ramelteon 8mg/day first dispensed at baseline. New two week supply of study medication dispensed at each biweekly visit for 8 consecutive weeks. | Drug | 1 |
| PlaceboTwo week supply of placebo tablets first dispensed at baseline. New two week supply of placebo dispensed at each biweekly visit for 8 consecutive weeks. | Drug | 2 |
Primary outcome
Change in Waist Circumference
Time frame: Baseline and Week 8
A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.
Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Time frame: Baseline and Week 8
A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8.
Change in Abdominal Fat (DEXA).
Time frame: Baseline and Week 8
A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15328901Ananth J, Venkatesh R, Burgoyne K, Gadasalli R, Binford R, Gunatilake S. Atypical antipsychotic induced weight gain: pathophysiology and management. Ann Clin Psychiatry. 2004 Apr-Jun;16(2):75-85. doi: 10.1080/10401230490453293.
- Background: PubMed 16107179Henderson DC. Schizophrenia and comorbid metabolic disorders. J Clin Psychiatry. 2005;66 Suppl 6:11-20.
- Background: PubMed 11825099Henderson DC. Atypical antipsychotic-induced diabetes mellitus: how strong is the evidence? CNS Drugs. 2002;16(2):77-89. doi: 10.2165/00023210-200216020-00001.
- Background: PubMed 16841629Henderson DC, Copeland PM, Borba CP, Daley TB, Nguyen DD, Cagliero E, Evins AE, Zhang H, Hayden DL, Freudenreich O, Cather C, Schoenfeld DA, Goff DC. Glucose metabolism in patients with schizophrenia treated with olanzapine or quetiapine: a frequently sampled intravenous glucose tolerance test and minimal model analysis. J Clin Psychiatry. 2006 May;67(5):789-97. doi: 10.4088/jcp.v67n0513.
- Background: PubMed 15151456Casey DE, Haupt DW, Newcomer JW, Henderson DC, Sernyak MJ, Davidson M, Lindenmayer JP, Manoukian SV, Banerji MA, Lebovitz HE, Hennekens CH. Antipsychotic-induced weight gain and metabolic abnormalities: implications for increased mortality in patients with schizophrenia. J Clin Psychiatry. 2004;65 Suppl 7:4-18; quiz 19-20. No abstract available.
- Background: PubMed 10553730Allison DB, Mentore JL, Heo M, Chandler LP, Cappelleri JC, Infante MC, Weiden PJ. Antipsychotic-induced weight gain: a comprehensive research synthesis. Am J Psychiatry. 1999 Nov;156(11):1686-96. doi: 10.1176/ajp.156.11.1686.
- Background: PubMed 11926934Newcomer JW, Haupt DW, Fucetola R, Melson AK, Schweiger JA, Cooper BP, Selke G. Abnormalities in glucose regulation during antipsychotic treatment of schizophrenia. Arch Gen Psychiatry. 2002 Apr;59(4):337-45. doi: 10.1001/archpsyc.59.4.337.
- Background: PubMed 15630069Henderson DC, Cagliero E, Copeland PM, Borba CP, Evins AE, Hayden D, Weber MT, Anderson EJ, Allison DB, Daley TB, Schoenfeld D, Goff DC. Glucose metabolism in patients with schizophrenia treated with atypical antipsychotic agents: a frequently sampled intravenous glucose tolerance test and minimal model analysis. Arch Gen Psychiatry. 2005 Jan;62(1):19-28. doi: 10.1001/archpsyc.62.1.19.
- Background: PubMed 9753305Bonora E, Kiechl S, Willeit J, Oberhollenzer F, Egger G, Targher G, Alberiche M, Bonadonna RC, Muggeo M. Prevalence of insulin resistance in metabolic disorders: the Bruneck Study. Diabetes. 1998 Oct;47(10):1643-9. doi: 10.2337/diabetes.47.10.1643.
- Background: PubMed 16046308Kitabchi AE, Temprosa M, Knowler WC, Kahn SE, Fowler SE, Haffner SM, Andres R, Saudek C, Edelstein SL, Arakaki R, Murphy MB, Shamoon H; Diabetes Prevention Program Research Group. Role of insulin secretion and sensitivity in the evolution of type 2 diabetes in the diabetes prevention program: effects of lifestyle intervention and metformin. Diabetes. 2005 Aug;54(8):2404-14. doi: 10.2337/diabetes.54.8.2404.
- Background: PubMed 8247074Lillioja S, Mott DM, Spraul M, Ferraro R, Foley JE, Ravussin E, Knowler WC, Bennett PH, Bogardus C. Insulin resistance and insulin secretory dysfunction as precursors of non-insulin-dependent diabetes mellitus. Prospective studies of Pima Indians. N Engl J Med. 1993 Dec 30;329(27):1988-92. doi: 10.1056/NEJM199312303292703.
- Background: PubMed 16823479Semenkovich CF. Insulin resistance and atherosclerosis. J Clin Invest. 2006 Jul;116(7):1813-22. doi: 10.1172/JCI29024.
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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.
David C. Henderson, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramelteon in people with Schizophrenia and Schizoaffective Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 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 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 13 Sep 2012). 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 Waist Circumference (time frame: Baseline and Week 8). The study lists 3 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 NCT00595504, which also lists 62 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 13 Sep 2012.