Trial · NCT01838681
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Full Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | Full remission is defined as a Montomery and Åsberg Depression Rating Scale (MADRS) total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomized treatment. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items. |
| Secondary | Full Functional Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | Full functional remission is defined as a Sheehan Disability Scale (SDS) total score \<=6 and all SDS domain scores \<=2 observed for at least 8 consecutive weeks during the randomised treatment period. The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. |
| Secondary | Full Global Score Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | Full global score remission is defined as a Clinical Global Impression - Severity of Illness (CGI-S) score \<=2 observed for at least 8 consecutive weeks during the randomised treatment period. The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis, on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. |
| Secondary | Total Time in Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | The total time the patient spends in remission during randomised treatment. Remission is defined as a MADRS total score \<=10 and a \>=50% decrease from randomisation in MADRS total score. Time in remission is defined as the sum of days over all periods between Period B visits where remission was obtained. The period between two visits is counted as in remission if the patient was in remission when the period started. |
| Secondary | Time to Full Remission During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | The time from randomisation until full remission has been obtained. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment. The time to full remission was calculated using Kaplan-Meier Methods. |
| Secondary | Full Remission Sustained During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | Full remission sustained is defined as having obtained full remission and remain in remission until completion of the study. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment. |
| Secondary | Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period | From randomisation to week 6 | The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items. |
| Secondary | Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items. |
| Secondary | Response at Week 6 During the Randomised Treatment Period | From randomisation to week 6 | Response is defined as a \>=50% decrease from randomisation in MADRS total score. |
| Secondary | Response at Week 24 During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | Response is defined as a \>=50% decrease from randomisation in MADRS total score. |
| Secondary | Remission at Week 6 During the Randomised Treatment Period | From randomisation to week 6 | Remission is defined as a MADRS total score \<=10 and a \>=50% decrease from randomisation in MADRS total score. |
| Secondary | Remission at Week 24 in the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | Remission is defined as a MADRS total score \<=10 and a \>=50% decrease from randomisation in MADRS total score. |
| Secondary | Change From Randomisation to Week 6 in SDS Total Score During the Randomised Treatment Period | From randomisation to week 6 | The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. |
| Secondary | Change From Randomisation to Week 24 in SDS Total Score During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. |
| Secondary | Change From Randomisation to Week 6 in CGI-S Score During the Randomised Treatment Period | From randomisation to week 6 | The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. |
| Secondary | Change From Randomisation to Week 24 in CGI-S Score During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. |
| Secondary | Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period | From randomisation to week 6 | The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70. |
| Secondary | Change From Randomisation to Week 24 in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q (SF)) Total Score During the Randomised Treatment Period | From randomisation to end of Period B (24 weeks) | The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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