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NCT01701284 · ClinicalTrials.gov registry record · NA
Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT01701284: Completed NA study, sponsored by Northwestern University.
NCT01701284 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01701284, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
Cancer is a leading cause of mortality and morbidity worldwide. In addition, cancer is associated with high rates of depression and anxiety among its sufferers, and cancer patients with depression usually have worse treatment outcomes and long-term survival. Surprisingly, many cancer patients with depression do not receive treatment for their depression, perhaps because treatments for cancer-related depression are usually adapted from those used in non-cancer populations and may not be suitable for cancer patients. Moreover, cancer patients with depression are more likely to have a long latency of anti-depressant drug action, negative drug-drug interactions with cancer chemotherapies and an increased susceptibility for systemic side effects. Repetitive transcranial magnetic stimulation (rTMS) is a new treatment modality for depression that affects the brain directly with no systemic side effects and poses no potential for drug-drug interactions. rTMS therapy was recently cleared by the FDA as an antidepressant treatment for treatment-resistant Major Depressive Disorder, and now is being evaluated for a wide array of additional psychiatric indications. This randomized, open label, two-arm, pilot study will investigate the safety, tolerability, feasibility and the efficacy of two forms of rTMS (i.e., left (fast) and right (slow) sided rTMS) in cancer-related depression. The study hypotheses are that rTMS will significantly reduce symptoms of depression and that right-sided slow rTMS will be more effective than left-sided fast rTMS for the treatment of severe anxiety.
Primary Outcome
This measure reports the overall change in depression severity(HDRS-17) from baseline (Week 0) at each follow-up assessment. Overall Change is defined as the score at each subsequent time point minus the score at Baseline. Scale Information: Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity. Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items. Range
Interventions
- DEVICE Repetitive Transcranial Magnetic Stimulation (rTMS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-12 |
| Est. Completion | 2023-05 |
| Phase | NA |
What the finished NCT01701284 record still lists
NCT01701284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Repetitive Transcranial Magnetic Stimulation (rTMS) is the first listed.
NCT01701284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01701284 about?
NCT01701284 is a clinical study titled "Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety". Cancer is a leading cause of mortality and morbidity worldwide. In addition, cancer is associated with high rates of depression and anxiety among its sufferers, and cancer patients with depression usually have worse treatment outcomes and long-term survival. Surprisingly, many cancer patients with d...
What is the current status of trial NCT01701284?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2012-12. Estimated completion is 2023-05.
What interventions are being tested in trial NCT01701284?
The interventions under investigation include: Repetitive Transcranial Magnetic Stimulation (rTMS) (DEVICE).
Who is sponsoring clinical trial NCT01701284?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01701284's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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