Trial · NCT03603561
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in depression severity clinician-rated | Screening, baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) | Hamilton rating scale for depression (HRSD-17); total scores ranging from 0 to 52. A higher score is indicative of greater depressive pathology |
| Secondary | Changes in depression severity self-report | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) | Beck Depression Inventory (BDI-II); total scores ranging from 0 to 63. Higher total scores indicate more severe depressive symptoms. |
| Secondary | Changes in suicidal thoughts - clinician-rated | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) | Columbia-suicide severity rating scale (total score ranges from 0 to 25; a higher score represent a higher intensity of suicidality) |
| Secondary | Changes in cognitive symptoms (1) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) | Continuous performance test (CPT), a measure of a person's sustained and selective attention: d-prime (the quotient of hits/false alarms that indicate the response sensitivity for discrimination of target from nontarget stimuli). Greater scores represent better ability to distinguish and detect X and non-X stimuli (better sustained attention) |
| Secondary | Changes in cognitive symptoms (2) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) | Symbol Digit Substitution Test (SDST), examining processing speed. Differentiating between the cognitive and the psychomotor processes of slowing (matching time and writing time; msec) |
| Secondary | Changes in cognitive symptoms (3) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) | Stroop test; examining response inhibition (Stroop response interference score) |
| Secondary | Changes in psychomotor symptoms (1) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) | CORE assessment of psychomotor functioning; total score ranging from 0 to 54. A higher score is indicative of psychomotor impairment (a score of 21 or more is indicative of melancholic depression) |
| Secondary | Changes in psychomotor symptoms (2) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) | Accelometer tool (MotionWatch 8®, CamNtech, Cambridge, UK; measuring gross motor performance): total day activity level (counts per hour). Lower values indicate reduction in gross motor activity. \*Cut-off levels from a control group are being collected in another research project of this research group. |
| Secondary | Changes in psychomotor symptoms (3) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) | Line-copying task (LCT): initiation and movement time (msec) |
| Secondary | Change in biological markers (1) | Baseline and 10 days after cTBS or sham (+/- day 14) | Plasma levels of C reactive protein (CRP) |
| Secondary | Change in biological markers (2) | Baseline and 10 days after cTBS or sham (+/- day 14) | Cytokines (pg/ml) |
| Secondary | Change in biological markers (3) | Baseline and 10 days after cTBS or sham (+/- day 14) | Kynurenines tryptophan catabolites (TRYCAT) levels (mmol/l) |
| Secondary | Change in biological markers (4) | Baseline and 10 days after cTBS or sham (+/- day 14) | Brain-derived neurotrophic factor (BDNF; ng/ml) |
| Secondary | Differences in adverse events following cTBS or sham - self report | 3 days after cTBS or sham (+/- day 7) | Adverse effects questionnaire |
| Secondary | Differences in development of (hypo)manic symptoms | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) | Young mania rating scale (YMRS): evaluates the presence and severity of mania. The score ranges from 0 to 60. Scores higher than 12 are indicative for mania, scores of 2 or lower indicate euthymia. |
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.
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