DepressionPhase 4NCT02989727
Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine
A Phase 4 study testing Lamotrigine in people with Depression and Bipolar Disorder, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The purpose of this study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Bipolar Disorder, Bipolar Depression
- What is being tested?
- Lamotrigine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2003to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must provide written and informed consent.
- Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks, with a HAMD-17 score of at least 18 with scores of 3 or more on Items 1 or 7.
- For females, be of non-childbearing potential, or of childbearing potential with a negative pregnancy test at screening and agrees to one of (a) abstinence from sex two weeks prior and five days after drug continuation/discontinuation, (b) personal or partner sterilization, (c) one method of hormonal contraception, or (d) two barrier methods of contraception.
- Acceptable results (within two times the normal limit) on laboratory screening tests (e.g., thyroid function).
Who cannot join
- Active suicidality.
- History of non-response to antidepressant treatment, or any previous treatment with lamotrigine.
- History of substance dependence in the past year, or abuse within the 4 weeks prior to study entry.
- Rapid cycling bipolar disorder.
- Receiving additional psychoactive medication (not including lorazepam for agitation), or has started a new course of psychotherapy within the last month.
- Received treatment for an anxiety or eating disorder within the last 12 months.
- Investigational drug use within the last month.
- History of epilepsy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Psychiatry, Royal University Hospital
Saskatoon, Saskatchewan, S7N0W8
About this study
Official title: Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine: Results From an 8-week, Multicenter, Double-blind, Placebo-controlled Trial
The purpose of this study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression. To do this, the investigators will re-analyze a previous clinical trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).
Read the detailed description
Patients suffering from depression with melancholic symptoms (i.e., anhedonia, flat affect, diurnal mood variation, terminal insomnia, psychomotor disturbances, decreased weight/appetite, and excessive guilt) respond better to certain antidepressants. Melancholic symptoms also occur in bipolar depression, although they have received less research. Lamotrigine has been shown to alter some of the biological processes that are known to occur in melancholic depression. The purpose of this study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression.
This study will re-analyze data from a previous 8-week, randomized, placebo-controlled trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677). The original study data was made available by GlaxoSmithKline as part of an initiative to make clinical trials data available for research use. Access was applied for via https://www.clinicalstudydatarequest.com.
The analysis strategy will be comparable to the original study, although the investigators will first classify participants as suffering from either melancholic or non-melancholic depression. The diagnosis of melancholic depression was established according to baseline responses to the Hamilton Depression Rating Scale (HAMD-17) and the Montgomery-Åsberg Depression Rating Scale (MADRS), according to the DSM-IV-TR diagnostic criteria. HAMD-17 and MADRS change scores will be compared between the treatment and placebo groups using Analysis of Variance (ANOVA). Both ANOVA models will include a test for an interaction between treatment group (lamotrigine vs. placebo) and melancholic depression (melancholic depression vs. non-melancholic depression). To handle missing data, each ANOVA model will be computed with only complete-case data first and subsequently using inverse probability weights that account for the probability of drop out. Inverse probability weights will be created based on covariates that predict missing responses. HAMD-17 and MADRS response rates between the treatment and placebo groups will be evaluated with a Cox proportional hazard regression analysis. There will be two separate analyses, one including participants with melancholic depression, and one including participants with non-melancholic depression. Statistical models will also adjust for baseline depression severity, if participants with melancholic depression are found to have more severe depressive symptoms at baseline.
Given the delay between antidepressant initiation and response, trial-and-error prescribing is an inevitably lengthy process. The investigators hope the results of this study will enable more timely and effective treatment for patients with bipolar depression.
- Conditions
- Depression, Bipolar Disorder, Bipolar Depression, Melancholia, Lamotrigine
- Being tested
- Lamotrigine, Placebos
- Medical subject headings
- Depression, Bipolar Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
Also called Lamictal
Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8.
PlacebosDrug
Also called Placebo
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine - melancholic depression | Experimental | Participants with melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day. Receives: Drug: Lamotrigine |
| Placebo - melancholic depression | Placebo comparator | Participants with melancholic depression who were randomly assigned to receive a placebo comparator. Receives: Drug: Placebos |
| Lamotrigine - nonmelancholic depression | Experimental | Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day. Receives: Drug: Lamotrigine |
| Placebo - nonmelancholic depression | Placebo comparator | Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores
Scale scores range from 0 to 60. This outcome is a change score calculated by subtracting Baseline from Week 8 scores.
Lower scores indicate greater improvement of depressive symptoms.
Measured: Eight weeks
Hamilton Depression Rating Scale (HAMD-17) Change Scores
Scale scores range from 0 to 52. This outcome is a change score calculated by subtracting Baseline from Week 8 scores.
Lower scores indicate greater improvement of depressive symptoms.
Measured: Eight weeks
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Measured: Eight weeks
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Measured: Seven weeks
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Measured: Six weeks
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Measured: Five weeks
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Measured: Four weeks
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Measured: Three weeks
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Measured: Two weeks
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Measured: One week
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Measured: Eight weeks
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Measured: Seven weeks
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Measured: Six weeks
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Measured: Five weeks
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Measured: Four weeks
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Measured: Three weeks
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Measured: Two weeks
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startNov 2003
- Primary completionAug 2005
- Study completionDec 2017
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 DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Evyn Peters, University of Saskatchewan
- Investigators
- Rudy C Bowen, FRCPC, Study director, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989727
- Sponsor's protocol ID
- GSK-SCA100223
- Status last verified
- Sep 2018
- First submitted
- 8 Dec 2016
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for the study (GSK-SCA100223; NCT00274677) is available through www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine: Results From an 8-week, Multicenter, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02989727
- Acronym / sponsor ID
- GSK-SCA100223
- Conditions
- Depression, Bipolar Disorder, Bipolar Depression, Melancholia, Lamotrigine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Posted 15 Feb 2019
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 study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression. To do this, the investigators will re-analyze a previous clinical trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).
Detailed description
Patients suffering from depression with melancholic symptoms (i.e., anhedonia, flat affect, diurnal mood variation, terminal insomnia, psychomotor disturbances, decreased weight/appetite, and excessive guilt) respond better to certain antidepressants. Melancholic symptoms also occur in bipolar depression, although they have received less research. Lamotrigine has been shown to alter some of the biological processes that are known to occur in melancholic depression. The purpose of this study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression.
This study will re-analyze data from a previous 8-week, randomized, placebo-controlled trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677). The original study data was made available by GlaxoSmithKline as part of an initiative to make clinical trials data available for research use. Access was applied for via https://www.clinicalstudydatarequest.com.
The analysis strategy will be comparable to the original study, although the investigators will first classify participants as suffering from either melancholic or non-melancholic depression. The diagnosis of melancholic depression was established according to baseline responses to the Hamilton Depression Rating Scale (HAMD-17) and the Montgomery-Åsberg Depression Rating Scale (MADRS), according to the DSM-IV-TR diagnostic criteria. HAMD-17 and MADRS change scores will be compared between the treatment and placebo groups using Analysis of Variance (ANOVA). Both ANOVA models will include a test for an interaction between treatment group (lamotrigine vs. placebo) and melancholic depression (melancholic depression vs. non-melancholic depression). To handle missing data, each ANOVA model will be computed with only complete-case data first and subsequently using inverse probability weights that account for the probability of drop out. Inverse probability weights will be created based on covariates that predict missing responses. HAMD-17 and MADRS response rates between the treatment and placebo groups will be evaluated with a Cox proportional hazard regression analysis. There will be two separate analyses, one including participants with melancholic depression, and one including participants with non-melancholic depression. Statistical models will also adjust for baseline depression severity, if participants with melancholic depression are found to have more severe depressive symptoms at baseline.
Given the delay between antidepressant initiation and response, trial-and-error prescribing is an inevitably lengthy process. The investigators hope the results of this study will enable more timely and effective treatment for patients with bipolar depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lamotrigine - melancholic depression | Experimental | Drug: LamotrigineParticipants with melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day. |
| Placebo - melancholic depression | Placebo comparator | Drug: PlacebosParticipants with melancholic depression who were randomly assigned to receive a placebo comparator. |
| Lamotrigine - nonmelancholic depression | Experimental | Drug: LamotrigineParticipants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day. |
| Placebo - nonmelancholic depression | Placebo comparator | Drug: PlacebosParticipants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must provide written and informed consent.
- Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks, with a HAMD-17 score of at least 18 with scores of 3 or more on Items 1 or 7.
- For females, be of non-childbearing potential, or of childbearing potential with a negative pregnancy test at screening and agrees to one of (a) abstinence from sex two weeks prior and five days after drug continuation/discontinuation, (b) personal or partner sterilization, (c) one method of hormonal contraception, or (d) two barrier methods of contraception.
- Acceptable results (within two times the normal limit) on laboratory screening tests (e.g., thyroid function).
Key exclusion criteria (8 listed)
- Active suicidality.
- History of non-response to antidepressant treatment, or any previous treatment with lamotrigine.
- History of substance dependence in the past year, or abuse within the 4 weeks prior to study entry.
- Rapid cycling bipolar disorder.
- Receiving additional psychoactive medication (not including lorazepam for agitation), or has started a new course of psychotherapy within the last month.
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 |
|---|---|---|
| LamotrigineAlso: LamictalLamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8. | Drug | Lamotrigine - melancholic depression, Lamotrigine - nonmelancholic depression |
| PlacebosAlso: PlaceboPlacebo tablets | Drug | Placebo - melancholic depression, Placebo - nonmelancholic depression |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores
Time frame: Eight weeks
Scale scores range from 0 to 60. This outcome is a change score calculated by subtracting Baseline from Week 8 scores. Lower scores indicate greater improvement of depressive symptoms.
Hamilton Depression Rating Scale (HAMD-17) Change Scores
Time frame: Eight weeks
Scale scores range from 0 to 52. This outcome is a change score calculated by subtracting Baseline from Week 8 scores. Lower scores indicate greater improvement of depressive symptoms.
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Eight weeks
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Seven weeks
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Six weeks
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Five weeks
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Four weeks
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Three weeks
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Two weeks
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: One week
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Time frame: Eight weeks
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Time frame: Seven weeks
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Time frame: Six weeks
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Time frame: Five weeks
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Time frame: Four weeks
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Time frame: Three weeks
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Time frame: Two weeks
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Time frame: One week
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The ClinicalTrials.gov posting for the original study (GSK-SCA100223; NCT00274677) from which data for the present study was obtained.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for the study (GSK-SCA100223; NCT00274677) is available through www.clinicalstudydatarequest.com.
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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.
Rudy C Bowen, FRCPC study director
University of Saskatchewan
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 Lamotrigine in people with Depression and Bipolar Disorder, run by University of Saskatchewan at 1 site in Canada.
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 8 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 15 Feb 2019. 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 Canada. 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 15 Feb 2019). 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?
Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores (time frame: Eight weeks). The study lists 18 primary outcomes in all. 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 15 Feb 2019.