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A Single Blind Study of Cranial Electrical Stimulation in Bipolar II Disorder
NCT01909011 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to assess the antidepressant effects of Cranial Electrotherapy Stimulation (CES) in the depressed phase of bipolar II disorder.; to examine the safety of daily CES in bipolar II patients; and to examine the effects of 20 minutes of daily CES on EEG reading. The investigators hypothesize: 1. The CES will reduce symptom severity more than sham (placebo) CES. 2. That CES administered for 20 minutes daily for four weeks is safe and well tolerated when treating bipolar II patients. 3. That CES will shift the alpha and beta power fractions of EEG downward, and that this shift correlates with a decrease in level of anxiety and depression
Conditions Studied
Interventions
- DEVICE Active CES
- DEVICE Sham CES
Study Locations (1)
New York
- Beth Israel Medical Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01909011
The ClinicalTrials.gov registry entry for NCT01909011 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Medical Center, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Bi-polar II Disorder appearing as the primary indexed condition, and to 2 interventions — of which Active CES is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01909011 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01909011 about?
NCT01909011 is a clinical study titled "A Single Blind Study of Cranial Electrical Stimulation in Bipolar II Disorder". The purpose of this study is to assess the antidepressant effects of Cranial Electrotherapy Stimulation (CES) in the depressed phase of bipolar II disorder.; to examine the safety of daily CES in bipolar II patients; and to examine the effects of 20 minutes of daily CES on EEG reading. The investig...
What is the current status of trial NCT01909011?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2013-01. Estimated completion is 2014-05.
What conditions does trial NCT01909011 study?
This clinical trial studies the following conditions: Bi-polar II Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01909011?
The interventions under investigation include: Active CES (DEVICE), Sham CES (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01909011?
This trial is sponsored by Beth Israel Medical Center, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01909011 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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