Trial · NCT06705478
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Beck Depression Inventory-II (BDI-II/BDI-2) total score defined as the sum of all symptom scores | Baseline, Week 24 | |
| Primary | Occurrence of Grade ≥3 Adverse Events (AEs) or Grade ≥2 neuropsychiatric AEs related to study treatment | From study treatment administration through Week 24 | |
| Primary | Occurrence of Grade ≥2 neuropsychiatric AEs related to study treatment | From study treatment administration through Week 24 | |
| Secondary | Change in major depressive disorder (MDD) caseness, defined as the number of symptoms present from 0 to 9, of the symptoms of major depressive disorder | Baseline, Week 24 | |
| Secondary | Complete remission of the major depressive episode defined as a score of 0 on all of the 9 symptoms | Baseline, Week 24 | |
| Secondary | Change in neuropsychological (NP) z-score as assessed through 4 composite domain scores | Baseline, Week 24 | Each domain score is calculated as the average of the z-scores from the tests within the domain: * Outcome Domain 1: Cognitive Efficiency (Color Trails 1 and 2) * Outcome Domain 2: Verbal Learning and Memory (HVLT-R Learning Trials 1-3 Total and HVLT-R Delayed Recall) * Outcome Domain 3: Motor Skills (Grooved Pegboard, Non-dominant hand) * Outcome Domain 4: Language (Category Fluency Test \[Animals\]) |
| Secondary | Change in the medical outcomes study (MOS)-HIV mental health functioning summary score defined by the MOS-HIV Users Manual | Baseline, Week 24 | |
| Secondary | Change in the MOS-HIV cognitive functioning subscale score defined by the MOS-HIV Users Manual | Baseline, Week 24 | |
| Secondary | Occurrence of Grade ≥3 AEs or Grade ≥2 neuropsychiatric AEs (regardless of judged relationship to study treatment) | From study treatment administration through Week 24 | |
| Secondary | Occurrence of Grade ≥2 neuropsychiatric AEs (regardless of judged relationship to study treatment) | From study treatment administration through Week 24 | |
| Secondary | Number of participants with plasma HIV-1 RNA less than 50 copies/mL | Week 24 |
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
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GET https://conductscience.org/api/trials/v1/NCT06705478/registered