Trial · NCT00733980
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17). | Randomization (Week 0) and Week 6 | Intent to Treat (ITT) population consisted of all participants who gave informed consent, were randomized, received at least one dose of double-blind medication, and had at least one post-randomization efficacy assessment available (HAM D, IDS-SR CGI, HAM A, MOS, PSS). | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score. | Randomization (Week 0) and Week 1, 2 and 4 | ITT population. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A) | Randomization (Week 0) and Week 1, 2, 4 and Week 6 | ITT population. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score. | Randomization (Week 0) and Week 1, 2, 3,4 and Week 6 | ITT population | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17) | Randomization (Week 0) and Week 1, 2, 4 and Week 6 | ITT population. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6. | Weeks 1, 2, 4, and 6. | ITT population. Only those participants available at the specified time points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Time to Maintained Antidepressant Response at the End of Treatment Phase (Week 6) | Week 6 | Endpoint not evaluated. | ||
| SECONDARY | Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6. | Randomization (Week 0) and Weeks 1, 2, 4, and 6. | ITT population | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6. | Weeks 1, 2, 4, and 6. | perecntage of participants | NUMBER | |
| SECONDARY | Change From Randomization in the Medical Outcomes Study 12-item Sleep Module (MOS 12) at Week 6 | Randomization (Week 0) and Week 6 | ITT population. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization in the Cohen Perceived Stress Scale (PSS) at Week 6. | Randomization (Week 0) and Week 6. | ITT population. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 28-day FU (18 months) | All subject population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Sign of Potential Clinical Importance (PCI) | Up to Week 10 | All subject population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Urinalysis Data | Randomization (Week 0), Week 3, Week 6/ Early withdrawal (EW) and 28 Day follow-up (FU) | All subject population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Electrocardiograph (ECG) Values | Randomization (Week 0), Week 4, Week 6 and 28 Day follow-up | All subject population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Hematology Values of PCI-Platelet | Upto 28-day FU | All Subject population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range | Upto Week 10 | All subject population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hormonal Data of PCI | up to Week 10 | All subject population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Discontinuation-Emergent Signs and Symptoms | At Week 6, 7-day (D) FU and 28-D FU | All subject population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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GET https://conductscience.org/api/trials/v1/NCT00733980/outcomes