Trial · NCT00616655
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater | Baseline to Week 8 | ITT Population: /The ITT population will include all randomized subjects who received at least one does of study medication during the double-blind period. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | unit on a scale | MEAN |
| SECONDARY | Change in Individual Item Scores on HAM-A | Baseline, Weeks 2, 4, 6, 8 | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impression- Improvement (CGI-I) | Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 2, 4, 6, 8 | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | participants | NUMBER |
| SECONDARY | Hamilton Anxiety Scale (HAM-A) Remission | Week 2, 4, 6, 8 based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | participants | NUMBER |
| SECONDARY | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline Insomnia Severity Index (ISI) Total Score | Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline Sheehan Disability Scale (SDS) | Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline Epworth Sleepiness Scale (ESS) | Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00616655/outcomes