SchizophreniaPhase 2/3NCT00419146
Treatment of Schizophrenia With an Omega-3 Fatty Acid (EPA) and Antioxidants
A Phase 2/3 study testing Ethyl-eicosapentaenoic acid (EPA) and Vitamins E + C in people with Schizophrenia and Schizophreniform Disorders, run by University Hospital, Aker at 1 site in Norway.
Trial summary
The purpose of this trial is to study the effect of adding the omega-3 fatty acid EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorders, Schizoaffective Disorder
- What is being tested?
- Ethyl-eicosapentaenoic acid (EPA) and Vitamins E + C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2001to Apr 2004
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with schizophrenia, schizophreniform disorder or schizoaffective disorder (DSM-IV)
- Admitted to a psychiatric hospital/department within the previous twenty-one days before screening
- Less than fifteen years, in retrospect, since first psychotic symptoms (DSM-IV 295, criteria A,1-4)
- Age 18-40 years
- Speaks fluently a Scandinavian language
- A written informed consent must be obtained before any trial-related activities
Who cannot join
- A diagnosis of substance dependence (DSM-IV)
- Known allergy to study medication
- Currently taking warfarin or having anamnestic indicators of impaired haemostasis (profuse bleeding, except epistaxis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Placebo-controlled Trial of Eicosapentaenoic Acid (EPA) and Antioxidant Supplementation in the Treatment of Schizophrenia and Related Disorders
The purpose of this trial is to study the effect of adding the omega-3 fatty acid EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.
Read the detailed description
Objective:
Study the effect of adding Ethyl-EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.
Methods and material:
- Design: Multicentre, randomized, double-blind, placebo-controlled, fixed dose, 2x2 factorial, add-on clinical trial.
- Sample:
- Patients with schizophrenia, schizoaffective disorder or schizophreniform disorder (DSM-IV); aged 18-40 years; less than 15 years since first psychotic symptoms;admitted to a psychiatric department within the previous 21 days before screening; speaks fluently a Scandinavian language;treated with antipsychotics; written informed consent;no known allergy to trial agents;no substance dependence (DSM-IV);no warfarin currently or anamnestic indicators of impaired haemostasis. Planned: 200 patients. Actually included: 99 intent-to-treat patients.
- Healthy controls: aged 18-40 years;no mental disorder (DSM-IV). Included: 20 persons.
- Clinical assessments: Positive and Negative Syndrome Scale (PANSS) (main outcome variable). Self-report questionnaire. Adverse effects (UKURS). Neurocognitive assessment battery. Niacin skin flush test. General medical assessment.
- Blood samples: RBC fatty acids, S-α-tocopherol, F2-isoprostane (kits), monocyte mRNA Phospholipase A22 (PLA2) Gr4a and 6a (RT-PCR method), RBC Gr4a PLA2 concentration (ELISA technique), a range of other biochemical tests.
- Experimental treatment over 16 weeks: Ethyl-EPA 2 g/d or Placebo EPA and Vitamin E 364 mg/d + Vitamin C 1000 mg/d or Placebo Antioxidants
- Statistics: Linear Mixed Model for longitudinal analyses of effects; other uni- and multivariate methods (SPSS 12.0 - PASW Statistics 18).
- Being tested
- Ethyl-eicosapentaenoic acid (EPA), Vitamins E + C, Etyl EPA (placebo), Vitamins E+C (placebo)
- Keywords
- Schizophrenia, Schizophreniform disorders, Schizoaffective disorder, Psychotic disorders, Randomized Controlled Trials, Longitudinal Studies, Fatty Acids, Omega-3, Eicosapentaenoic Acid, Vitamins, Antioxidants, Ascorbic Acid, Alpha-Tocopherol, Placebos, Antipsychotic Agents, Oxidative Stress, Fatty Acids, Unsaturated, Phospholipases, Niacin, Adverse effects, Delusions
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Delusions, Hallucinations, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyl-eicosapentaenoic acid (EPA)Drug
Also called Provided by Laxdale Ltd., Scotland, UK
Capsules, 2 g per day for 16 weeks
Vitamins E + CDrug
Also called CellaVie (Ferrosan AS, Denmark)
RRR-alpha-tocopherol 392 mg + slow-release ascorbic acid 1000 mg per day, for 16 weeks
Etyl EPA (placebo)Other
Also called Placebo EPA
Paraffin oil. Capsules, each 0.5 g.
Vitamins E+C (placebo)Other
Also called Placebo CellaVie, provided by Ferrosan AS, Denmark
Tablets containing dicalciumphosphate
| Study group | Role | What they receive |
|---|---|---|
| Ethyl EPA (active) and Vitamins E + C (active) | Experimental | Not described Receives: Drug: Ethyl-eicosapentaenoic acid (EPA); Drug: Vitamins E + C |
| Ethyl EPA (active) and Vitamins E+C (placebo) | Experimental | Not described Receives: Drug: Ethyl-eicosapentaenoic acid (EPA); Other: Vitamins E+C (placebo) |
| Ethyl EPA (placebo) and Vitamins E+C (active) | Experimental | Not described Receives: Drug: Vitamins E + C; Other: Etyl EPA (placebo) |
| Ethyl EPA (placebo) and Vitamins E+C (placebo) | Placebo comparator | Not described Receives: Other: Vitamins E+C (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)- Total
Measured: Baseline - 8 weeks - 16 weeks
Secondary outcomes (42)
PANSS Subscales Negative, Positive, General Psychopathology
Measured: Weeks 0, 8, 16
GLOBAL ASSESSMENT OF FUNCTIONING- Split Version (S-GAF)
(S-GAF)Symptom Scale (S-GAF)Function Scale
Measured: Weeks 0, 8, 16
WONCA-COOP FUNCTIONAL HEALTH ASSESSMENT CHARTS
5 scales
Measured: Weeks 0, 8, 16
NIACIN SKIN FLUSH TEST
2 concentrations of niacin
Measured: Weeks 0, 8, 16
THE UKU SIDE EFFECT RATING SCALE (USERS)
- Sum of scores
- Patients with side effects
Measured: Weeks 0,4,8,12,16
SERIOUS ADVERSE EVENTS
Measured: Weeks 0,4,8,12,16
CONCOMITANT ANTIPSYCHOTIC MEDICATION
Defined Daily Doses (ATC/WHO)
Measured: Weeks 0,4,8,12,16
Kimura Recurring Recognition Figures Test
A sub-sample of patients. For logistic reasons, only some study sites could participate.
Measured: Weeks 0, 16
Hopkins Verbal Learning Test.
A sub-sample of patients. For logistic reasons, only some study sites could participate.
Measured: Weeks 0, 16
Continuous Performance Test
A sub-sample of patients. For logistic reasons, only some study sites could participate.
Measured: Weeks 0, 16
Hopkins Verbal Learning Test
A sub-sample of patients. For logistic reasons, only some study sites could participate.
Measured: Weeks 0, 16
Paced Auditory Serial Addition Test
A sub-sample of patients. For logistic reasons, only some study sites could participate.
Measured: Weeks 0, 16
Stroop Test
A sub-sample of patients. For logistic reasons, only some study sites could participate.
Measured: Weeks 0, 16
Digit Span
A sub-sample of patients. For logistic reasons, only some study sites could participate.
Measured: Weeks 0, 16
The Letter - Number Task
A sub-sample of patients. For logistic reasons, only some study sites could participate.
Measured: Weeks 0,16
Semantic and Category Fluency
A sub-sample of patients. For logistic reasons, only some study sites could participate.
Measured: Weeks 0, 16
Body Mass Index
Measured: Weeks 0, 16
Blood pressure - systolic, diastolic
Measured: Weeks 0, 16
Heart rate
Measured: Weeks 0, 16
Albumin
Serum
Measured: Weeks 0, 16
Urate
Serum
Measured: Weeks 0, 16
Glucose
Serum - fasting
Measured: Weeks 0, 16
Cholesterol
Serum - fasting
Measured: Weeks 0, 16
Triglycerides
Serum - fasting
Measured: Weeks 0, 16
Fatty acids in red blood cells
The concentrations of long-chain (C14-18) and very long-chain (C20-24)fatty acids in erythrocytes were measured. Fasting condition.
We selected DGLA, AA, EPA, DHA, total omega-3 Polyunsaturated Fatty Acids (PUFA), total omega-6 PUFA, PUFA and LCPUFA (long-chain PUFA) as outcome measures.
Measured: Weeks 0, 16
Alpha-tocopherol adjusted for [triglycerides]+[cholesterol].
Serum
Measured: Weeks 0, 16
Total antioxidant status
Serum
Measured: Weeks 0, 16
Malondialdehyde
Also called "TBARS". Serum
Measured: Weeks 0, 16
F2-isoprostane (8-epiPGF2-alpha)
Serum
Measured: Weeks 0, 16
Cytosolic PLA2 group IV in red blood cells(ELISA method)
Omitted from stastical analyses because of problems with the pre-analytic procedure (treatment the of blood)
Gene expression of mRNA for Phospholipase A2 (PLA2) groups IVa and VIa in monocytes.
Whole blood
Measured: Weeks 0, 16
Mean Corpuscular Haemoglobin Concentration (MCHC)
Whole blood
Measured: Weeks 0, 16
Mean Corpuscular Volume (MCV)
Whole blood
Measured: Weeks 0, 16
C- Reactive Protein (CRP)
Plasma
Measured: Weeks 0, 16
Haemoglobin
Whole blood
Measured: Weeks 0, 16
Leukocytes
Whole blood
Measured: Weeks 0, 16
Calcium
Serum
Measured: Weeks 0, 16
Sodium
Serum
Measured: Weeks 0, 16
Potassium
Serum
Measured: Weeks 0, 16
Ferritin
Serum
Measured: Weeks 0,16
Free thyroxin (T4)
Serum
Measured: Weeks 0, 16
Thyroid Stimulating Hormone (TSH)
Serum
Measured: Weeks 0, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startSep 2001
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Aker
- Sponsor type
- University, hospital or other
- Collaborators
- Diakonhjemmet Hospital, Stanley Medical Research Institute, Laxdale Ltd, Scandinavian Society for Psychopharmacology, Shipowner Emil Stray's legacy, Johanne and Einar Eilertsen's research fund, AstraZeneca, Solveig and Johan P. Sommer's foundation, Josef and Haldis Andresen's legacy, University of Oslo, Norwegian University of Science and Technology
- Investigators
- Håvard Bentsen, MD PhD, Study director, Aker University Hospital (-2004), Diakonhjemmet Hospital (2004-)Odd Lingjærde, MD PhD, Study chair, University Hospital, Aker
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419146
- Sponsor's protocol ID
- LA.01.07.0001
- Other IDs
- 01T-106 (Stanley M.R.I.,USA)
- Status last verified
- Aug 2010
- First submitted
- 5 Jan 2007
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Placebo-controlled Trial of Eicosapentaenoic Acid (EPA) and Antioxidant Supplementation in the Treatment of Schizophrenia and Related Disorders
- ClinicalTrials.gov ID
- NCT00419146
- Acronym / sponsor ID
- LA.01.07.0001
- Keywords
- Schizophrenia, Schizophreniform disorders, Schizoaffective disorder, Psychotic disorders, Randomized Controlled Trials, Longitudinal Studies, Fatty Acids, Omega-3, Eicosapentaenoic Acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital, AkerUniversity, hospital or other
- Collaborators
- Diakonhjemmet Hospital, Stanley Medical Research Institute, Laxdale Ltd, Scandinavian Society for Psychopharmacology, Shipowner Emil Stray's legacy, Johanne and Einar Eilertsen's research fund, AstraZeneca, Solveig and Johan P. Sommer's foundation, Josef and Haldis Andresen's legacy, University of Oslo, Norwegian University of Science and Technology
- Study start
- Sep 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 8 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to study the effect of adding the omega-3 fatty acid EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.
Detailed description
Objective:
Study the effect of adding Ethyl-EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.
Methods and material:
- Design: Multicentre, randomized, double-blind, placebo-controlled, fixed dose, 2x2 factorial, add-on clinical trial.
- Sample:
- Patients with schizophrenia, schizoaffective disorder or schizophreniform disorder (DSM-IV); aged 18-40 years; less than 15 years since first psychotic symptoms;admitted to a psychiatric department within the previous 21 days before screening; speaks fluently a Scandinavian language;treated with antipsychotics; written informed consent;no known allergy to trial agents;no substance dependence (DSM-IV);no warfarin currently or anamnestic indicators of impaired haemostasis. Planned: 200 patients. Actually included: 99 intent-to-treat patients.
- Healthy controls: aged 18-40 years;no mental disorder (DSM-IV). Included: 20 persons.
- Clinical assessments: Positive and Negative Syndrome Scale (PANSS) (main outcome variable). Self-report questionnaire. Adverse effects (UKURS). Neurocognitive assessment battery. Niacin skin flush test. General medical assessment.
- Blood samples: RBC fatty acids, S-α-tocopherol, F2-isoprostane (kits), monocyte mRNA Phospholipase A22 (PLA2) Gr4a and 6a (RT-PCR method), RBC Gr4a PLA2 concentration (ELISA technique), a range of other biochemical tests.
- Experimental treatment over 16 weeks: Ethyl-EPA 2 g/d or Placebo EPA and Vitamin E 364 mg/d + Vitamin C 1000 mg/d or Placebo Antioxidants
- Statistics: Linear Mixed Model for longitudinal analyses of effects; other uni- and multivariate methods (SPSS 12.0 - PASW Statistics 18).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ethyl EPA (active) and Vitamins E + C (active) | Experimental | Drug: Ethyl-eicosapentaenoic acid (EPA), Drug: Vitamins E + C |
| Ethyl EPA (active) and Vitamins E+C (placebo) | Experimental | Drug: Ethyl-eicosapentaenoic acid (EPA), Other: Vitamins E+C (placebo) |
| Ethyl EPA (placebo) and Vitamins E+C (active) | Experimental | Drug: Vitamins E + C, Other: Etyl EPA (placebo) |
| Ethyl EPA (placebo) and Vitamins E+C (placebo) | Placebo comparator | Other: Vitamins E+C (placebo) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with schizophrenia, schizophreniform disorder or schizoaffective disorder (DSM-IV)
- Admitted to a psychiatric hospital/department within the previous twenty-one days before screening
- Less than fifteen years, in retrospect, since first psychotic symptoms (DSM-IV 295, criteria A,1-4)
- Age 18-40 years
- Speaks fluently a Scandinavian language
Key exclusion criteria (3 listed)
- A diagnosis of substance dependence (DSM-IV)
- Known allergy to study medication
- Currently taking warfarin or having anamnestic indicators of impaired haemostasis (profuse bleeding, except epistaxis)
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 |
|---|---|---|
| Ethyl-eicosapentaenoic acid (EPA)Also: Provided by Laxdale Ltd., Scotland, UKCapsules, 2 g per day for 16 weeks | Drug | Ethyl EPA (active) and Vitamins E + C (active), Ethyl EPA (active) and Vitamins E+C (placebo) |
| Vitamins E + CAlso: CellaVie (Ferrosan AS, Denmark)RRR-alpha-tocopherol 392 mg + slow-release ascorbic acid 1000 mg per day, for 16 weeks | Drug | Ethyl EPA (active) and Vitamins E + C (active), Ethyl EPA (placebo) and Vitamins E+C (active) |
| Etyl EPA (placebo)Also: Placebo EPAParaffin oil. Capsules, each 0.5 g. | Other | Ethyl EPA (placebo) and Vitamins E+C (active) |
| Vitamins E+C (placebo)Also: Placebo CellaVie, provided by Ferrosan AS, DenmarkTablets containing dicalciumphosphate | Other | Ethyl EPA (active) and Vitamins E+C (placebo), Ethyl EPA (placebo) and Vitamins E+C (placebo) |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)- Total
Time frame: Baseline - 8 weeks - 16 weeks
42 secondary outcomes
PANSS Subscales Negative, Positive, General Psychopathology
Time frame: Weeks 0, 8, 16
GLOBAL ASSESSMENT OF FUNCTIONING- Split Version (S-GAF)
Time frame: Weeks 0, 8, 16
WONCA-COOP FUNCTIONAL HEALTH ASSESSMENT CHARTS
Time frame: Weeks 0, 8, 16
NIACIN SKIN FLUSH TEST
Time frame: Weeks 0, 8, 16
THE UKU SIDE EFFECT RATING SCALE (USERS)
Time frame: Weeks 0,4,8,12,16
SERIOUS ADVERSE EVENTS
Time frame: Weeks 0,4,8,12,16
CONCOMITANT ANTIPSYCHOTIC MEDICATION
Time frame: Weeks 0,4,8,12,16
Kimura Recurring Recognition Figures Test
Time frame: Weeks 0, 16
Hopkins Verbal Learning Test.
Time frame: Weeks 0, 16
Continuous Performance Test
Time frame: Weeks 0, 16
Hopkins Verbal Learning Test
Time frame: Weeks 0, 16
Paced Auditory Serial Addition Test
Time frame: Weeks 0, 16
Stroop Test
Time frame: Weeks 0, 16
Digit Span
Time frame: Weeks 0, 16
The Letter - Number Task
Time frame: Weeks 0,16
Semantic and Category Fluency
Time frame: Weeks 0, 16
Body Mass Index
Time frame: Weeks 0, 16
Blood pressure - systolic, diastolic
Time frame: Weeks 0, 16
Heart rate
Time frame: Weeks 0, 16
Albumin
Time frame: Weeks 0, 16
Urate
Time frame: Weeks 0, 16
Glucose
Time frame: Weeks 0, 16
Cholesterol
Time frame: Weeks 0, 16
Triglycerides
Time frame: Weeks 0, 16
Fatty acids in red blood cells
Time frame: Weeks 0, 16
Alpha-tocopherol adjusted for [triglycerides]+[cholesterol].
Time frame: Weeks 0, 16
Total antioxidant status
Time frame: Weeks 0, 16
Malondialdehyde
Time frame: Weeks 0, 16
F2-isoprostane (8-epiPGF2-alpha)
Time frame: Weeks 0, 16
Cytosolic PLA2 group IV in red blood cells(ELISA method)
Gene expression of mRNA for Phospholipase A2 (PLA2) groups IVa and VIa in monocytes.
Time frame: Weeks 0, 16
Mean Corpuscular Haemoglobin Concentration (MCHC)
Time frame: Weeks 0, 16
Mean Corpuscular Volume (MCV)
Time frame: Weeks 0, 16
C- Reactive Protein (CRP)
Time frame: Weeks 0, 16
Haemoglobin
Time frame: Weeks 0, 16
Leukocytes
Time frame: Weeks 0, 16
Calcium
Time frame: Weeks 0, 16
Sodium
Time frame: Weeks 0, 16
Potassium
Time frame: Weeks 0, 16
Ferritin
Time frame: Weeks 0,16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2011.
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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.
Håvard Bentsen, MD PhD study director
Aker University Hospital (-2004), Diakonhjemmet Hospital (2004-)
Odd Lingjærde, MD PhD study chair
University Hospital, Aker
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ethyl-eicosapentaenoic acid (EPA) and Vitamins E + C in people with Schizophrenia and Schizophreniform Disorders, run by University Hospital, Aker at 1 site in Norway.
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 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2011. 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 Norway. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive and Negative Syndrome Scale (PANSS)- Total (time frame: Baseline - 8 weeks - 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2011.