Trial · NCT01798407
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 HDRS^17 score from baseline to 6 months after the commencement of stimulation | baseline, Month 6, Month 12 and 18 months | 'Response' is categorically defined as a ≥ 50% reduction in the HDRS17 score relative to the baseline assessment. 'Remission' is defined as an absolute HDRS17 score \< 8. Study success criteria will be defined as ≥ 3 of the 6 patients meeting the individual subject success criteria of response or remission by HDRS17 score at the 6 month time point. |
| Secondary | MADRS (Montgomery and Asberg Depression Rating Scale) | baseline, Month 6, Month 12 and 18 months | Clinician administered evaluation of depressive symptoms |
| Secondary | Clinical Global Impression of Severity (CGI-S) | baseline, Month 6, Month 12 and 18 months | Clinician Administered assessment |
| Secondary | Clinical Global Impression of Improvement (CGI-I) | baseline, Month 6, Month 12 and 18 months | Clinician administered assessment |
| Secondary | Young Mania Rating Scale (YMRS) | baseline, Month 6, Month 12 and 18 months | Clinician administered assessment |
| Secondary | Columbia Suicide Severity Rating Scale (C-SSRS) | baseline, Month 6, Month 12 and 18 months | Clinician administered assessment |
| Secondary | Neuropsychological Battery | baseline, Month 6, Month 12 and 18 months | Clinician administered assessment includes WAIS-IV subscales subscales: Digit Span, Information, Coding, Similarities, and Visual Puzzles; TMT (Trail Making Tests) A and B; Neuropsychological Assessment Battery (NAB): Naming Test; JLO, (Benton Judgment of Line Orientation Test \[Forms H and V\]); HVLT-R (Hopkins Verbal Learning Test-R \[Forms 1, 2, 3, and 4\]); BVMT-R (Brief Visual Spatial Memory Test, Revised \[Forms 1, 2, 3, and 4\]); GPT (Grooved Pegboard Test); COWAT (Controlled Oral Word Association Test) with semantic fluency; WCST (Wisconsin Card Sorting Test) - short version (64 item); Stroop (Stroop Color Word Test); IGT(Iowa Gambling Task) |
| Secondary | QIDS-SR (Quick Inventory of Depressive Symptomatology) | baseline, Month 6, Month 12 and 18 months | Subject self rated assessment |
| Secondary | Generalized Anxiety Disorder 7-item Scale (GAD-7) | baseline, Month 6, Month 12 and 18 months | Subject self rated assessment |
| Secondary | Sheehan Disability Scale | baseline, Month 6, Month 12 and 18 months | Subject self rated assessment |
| Secondary | PRISE (The Patient Rated Inventory of Side Effects) | baseline, Month 6, Month 12 and 18 months | Subject self report of adverse events (and collection) |
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/NCT01798407/registered