Bipolar Disorder I or IIPhase 3NCT00259272

Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine

A Phase 3 study testing olanzapine in people with Bipolar Disorder I or II, run by Eli Lilly and Company at 16 sites in France.

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

A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bipolar Disorder I or II
What is being tested?: olanzapine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 141 participants
Where: 16 sitesFrance
Study dates: Nov 2005to May 2008
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

Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria for Bipolar Disorder
currently or most recently in a Manic Episode (Single Manic Episode or Most Recent Episode Manic) or
currently or most recently in a Hypomanic Episode or
currently or most recently in a Mixed Episode or
currently or most recently in a Major Depressive Episode
and confirmed by the module D of the SCID (Semi-Structured Interview).
Patients must be more than 18 of age at Visit 0.

Who cannot join

A valid current or lifetime DSM-IV-TR Axis I or II diagnosis which could interfere, at the investigator's opinion, with the evaluation.
Patients on antidepressant or mood stabilizer therapy one week (four weeks with fluoxetine) prior to Visit 1, with the exception of mood stabilizer therapy considered in the opinion of the investigator as an efficient treatment for at least one year prior to the study.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

France16 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Andilly, 95580
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Bordeaux, 33076
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Cornebarrieu, 31700
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Créteil, 94010
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La Rochelle, 17000
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La Seyne-sur-Mer, 83500
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Lyon, 69322
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Marseille, 13385
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Montpellier, 34094
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Nîmes, 30029
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Orvault, 44700
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Paris, 75019
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pin-Balma, 31130
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Plaisir, 78373
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Poitiers, 86021
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toulouse, 31300

Other trials in France

About this study

Official title: Phase IIIb, Multicenter, Single-Arm Open-Label Study, Supporting the Development and the Validation of the MATHYS Scale (Multidimensional Assessment of THYmic States) in a Population of Bipolar Patients Treated With Olanzapine, Either in-Label (Manic and Mixed Patients) and Off-Label (Hypomanic and Bipolar Depression)

Conditions: Bipolar Disorder I or II
Being tested: olanzapine

What participants receive

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

olanzapineDrug
Also called LY170053, Velotab, Zydis
5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.

Study groups in NCT00259272
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: olanzapine

What is being measured

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

Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
A visual analogic scale consisting of 20 items. Item scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18 which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.
Measured: Baseline, 6 Weeks, 24 weeks
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
This analysis indicates whether the total score is correct and provides enough information, or if subscores need to be calculated. Eigen value, proportion and cumulative are statistical parameters from the Principal Component Analysis, given for each factor.
Measured: Baseline

Secondary outcomes (18)

Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).
Measured: Baseline, 6 Weeks, 24 Weeks
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score
The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).
Measured: Baseline, 6 Weeks, 24 Weeks
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
Measured: Baseline, 6 Weeks, 24 Weeks
Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)
Measured: baseline and 24 weeks
Increases and Decreases in Fasting Glucose Levels
Measured: over 24 weeks
Mean Change From Baseline to 24 Week Endpoint in Lipids
Baseline, change from baseline, and percent change for the following lipids are presented: Total Cholesterol (TC), High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), and Triglycerides (TG).
Measured: Baseline and 24 Weeks
Increases and Decreases in Lipid Levels
Measured: over 24 weeks
Mean Change From Baseline to 24 Week Endpoint in Weight
Measured: Baseline and 24 weeks
Weight Gain Compared to Baseline
Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline
Measured: over 24 weeks
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Measured: 24 weeks
MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment
A visual analogic scale consisting of 20 items. Items scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18, which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.
Measured: Baseline
Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment
The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).
Measured: Baseline, 6 Weeks, 24 Weeks
Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).
Measured: Baseline, 6 Weeks, 24 Weeks
Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
Measured: Baseline, 6 Weeks, 24 Weeks
Emotional Reactivity With the Physiological Measure of Heart Rate
to assess emotional reactivity with the physiological measure of heart rate, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients
Measured: 12 weeks
Emotional Reactivity With the Physiological Measure of Skin Conductance
To assess emotional reactivity with the physiological measure of skin conductance, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.
Measured: 12 weeks
Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink
To assess emotional reactivity with the physiological measure of startle reflex response by measuring the latency of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.
Measured: 12 weeks
Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink
To assess emotional reactivity with the physiological measure of startle reflex response - by measuring the amplitude of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.
Measured: 12 weeks

Timeline

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

Nov 2005May 2008

First posted29 Nov 2005 (estimated)
Study startNov 2005
Primary completionMay 2008
Study completionMay 2008

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.
Other trials for Bipolar Disorder I or IIStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00259272
Sponsor's protocol ID: 9675
Other IDs: F1D-FP-S057
Status last verified: Apr 2009
First submitted: 28 Nov 2005
Last updated: 24 Jun 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
RecruitingPhase 2
ALTO-100 in Bipolar Disorder With Depression (BD-D)
Bipolar Disorder I or II With a Major Depressive Episode
Active, not recruitingPhase 3
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Bipolar Disorder, Bipolar Depression
Active, not recruitingPhase 3
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Bipolar Depression, Bipolar I Disorder
Active, not recruitingPhase 2
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
Bipolar I or II Disorder

All Bipolar Disorder I or II trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIIb, Multicenter, Single-Arm Open-Label Study, Supporting the Development and the Validation of the MATHYS Scale (Multidimensional Assessment of THYmic States) in a Population of Bipolar Patients Treated With Olanzapine, Either in-Label (Manic and Mixed Patients) and Off-Label (Hypomanic and Bipolar Depression)
ClinicalTrials.gov ID: NCT00259272
Acronym / sponsor ID: 9675
Conditions: Bipolar Disorder I or II
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 29 Nov 2005 (estimated)
Results: Posted 24 Jun 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A	Experimental	Drug: olanzapine

Who may qualify

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

Key inclusion criteria (7 listed)

Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria for Bipolar Disorder
Patients must be more than 18 of age at Visit 0.

Key exclusion criteria (2 listed)

A valid current or lifetime DSM-IV-TR Axis I or II diagnosis which could interfere, at the investigator's opinion, with the evaluation.
Patients on antidepressant or mood stabilizer therapy one week (four weeks with fluoxetine) prior to Visit 1, with the exception of mood stabilizer therapy considered in the opinion of the investigator as an efficient treatment for at least one year prior to the 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
olanzapineAlso: LY170053, Velotab, Zydis5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.	Drug	A

Primary outcome

Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
Time frame: Baseline, 6 Weeks, 24 weeks
A visual analogic scale consisting of 20 items. Item scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18 which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Time frame: Baseline
This analysis indicates whether the total score is correct and provides enough information, or if subscores need to be calculated. Eigen value, proportion and cumulative are statistical parameters from the Principal Component Analysis, given for each factor.

18 secondary outcomes

Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score
Time frame: Baseline, 6 Weeks, 24 Weeks
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score
Time frame: Baseline, 6 Weeks, 24 Weeks
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score
Time frame: Baseline, 6 Weeks, 24 Weeks
Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)
Time frame: baseline and 24 weeks
Increases and Decreases in Fasting Glucose Levels
Time frame: over 24 weeks
Mean Change From Baseline to 24 Week Endpoint in Lipids
Time frame: Baseline and 24 Weeks
Increases and Decreases in Lipid Levels
Time frame: over 24 weeks
Mean Change From Baseline to 24 Week Endpoint in Weight
Time frame: Baseline and 24 weeks
Weight Gain Compared to Baseline
Time frame: over 24 weeks
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Time frame: 24 weeks
MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment
Time frame: Baseline
Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment
Time frame: Baseline, 6 Weeks, 24 Weeks
Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment
Time frame: Baseline, 6 Weeks, 24 Weeks
Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment
Time frame: Baseline, 6 Weeks, 24 Weeks
Emotional Reactivity With the Physiological Measure of Heart Rate
Time frame: 12 weeks
Emotional Reactivity With the Physiological Measure of Skin Conductance
Time frame: 12 weeks
Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink
Time frame: 12 weeks
Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink
Time frame: 12 weeks

Results and safety

Results posted to the registry on 24 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Manic Episode	36	21
Hypomanic Episode	31	24
Mixed Episode	26	21
Depressive Episode	48	27

Primary outcome: Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score

Time frame: Baseline, 6 Weeks, 24 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Manic Episode n = 36	Hypomanic Episode n = 31	Mixed Episode n = 26	Depressive Episode n = 48
Baseline (n=34, 31, 25, 48)	140.55 (22.18)	136.52 (22.45)	116.74 (21.30)	76.88 (22.91)
6 Week Endpoint (n=31, 31, 25, 44)	115.37 (23.09)	105.15 (23.10)	101.58 (22.55)	93.41 (23.71)
Change from 6 Week Endpoint (n=30, 31, 24, 44)	-22.91 (28.70)	-31.37 (30.46)	-13.32 (26.37)	17.17 (26.62)
24 Week Endpoint (n=35, 31, 26, 47)	115.15 (24.84)	103.16 (23.03)	91.56 (25.19)	94.58 (27.09)
Change from 24 Week Endpoint (n=34, 31, 25, 47)	-24.67 (24.83)	-33.36 (33.61)	-26.08 (40.51)	17.04 (31.81)

Population analysed: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.

Primary outcome: Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix

Time frame: Baseline. Number. Unit: value

Measure	Eigen Value n = 141	Proportion n = 141	Cumulative n = 141
Factor 1	8.77	0.4383	0.4383
Factor 2	2.01	0.1006	0.5389
Factor 3	1.19	0.0594	0.5984
Factor 4	1.042	0.0521	0.6505
Factor 5	0.98	0.0490	0.6995
Factor 6	0.79	0.0397	0.7392
Factor 7	0.69	0.0347	0.7739
Factor 8	0.64	0.0322	0.8061

Population analysed: Matrix based on data from all 141 participants.

18 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olanzapine	14 of ?	53 of ?	Not reported

Limitations and caveats (from the sponsor): Fewer patients than planned were enrolled in the study. Not all the analyses (Principal Component Analysis, scree plot to define the structure) could be provided due to the specific formatting of the clinicaltrials.gov databank.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bipolar Disorder I or II

Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
RecruitingPhase 2
ALTO-100 in Bipolar Disorder With Depression (BD-D)
Bipolar Disorder I or II With a Major Depressive Episode
Active, not recruitingPhase 3
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
Bipolar Disorder, Bipolar Depression
Active, not recruitingPhase 3
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Bipolar Depression, Bipolar I Disorder
Active, not recruitingPhase 2
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
Bipolar I or II Disorder

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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT-5 hours, EST) study director

Eli Lilly and Company

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing olanzapine in people with Bipolar Disorder I or II, run by Eli Lilly and Company at 16 sites in France.

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 7 inclusion and 2 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 24 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. 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. 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 24 Jun 2009). 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?

Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score (time frame: Baseline, 6 Weeks, 24 weeks). The study lists 2 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 NCT00259272.

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 24 Jun 2009; AzTrials last refreshed its copy on 26 Oct 2026.