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Trial · NCT03603561

Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression

NCT03603561, Not applicable, Unknown, Universiteit Antwerpen

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression. Trials, record NCT03603561. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03603561

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression
NCT number
NCT03603561
Status
Unknown
Phases
Not applicable
Enrollment
40 participants, estimated
Lead sponsor
Universiteit Antwerpen
Conditions
Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder, Depression, Mood Disorders, Mental Disorder
Interventions
cTBS, Sham cTBS
First posted
2018-07-27
Last updated
2019-04-25

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChanges in depression severity clinician-ratedScreening, 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
SecondaryChanges in depression severity self-reportBaseline, 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.
SecondaryChanges in suicidal thoughts - clinician-ratedBaseline, 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)
SecondaryChanges 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)
SecondaryChanges 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)
SecondaryChanges 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)
SecondaryChanges 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)
SecondaryChanges 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.
SecondaryChanges 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)
SecondaryChange in biological markers (1)Baseline and 10 days after cTBS or sham (+/- day 14)Plasma levels of C reactive protein (CRP)

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
15664172BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Continuous Performance TestSecondary outcomeConductCognition
Stroop Color-Word TestSecondary outcomeConductCognition

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

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 trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03603561

GET https://conductscience.org/api/trials/v1/NCT03603561/registered