Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01909011 · ClinicalTrials.gov registry record · NA
A Single Blind Study of Cranial Electrical Stimulation in Bipolar II Disorder
A NA study of Bipolar II Disorder, sponsored by Beth Israel Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01909011: Completed NA study of Bipolar II Disorder, sponsored by Beth Israel Medical Center.
NCT01909011 is a NA study of Bipolar II Disorder that has completed, run by Beth Israel Medical Center. The registered enrollment target is 16 participants, below the 82-participant average among 14 other Bipolar II Disorder trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01909011, a NA study of Bipolar II Disorder, has completed, sponsored by Beth Israel Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
BDI is a validated, self-report measure used to assess the level of depression symptom severity. BDI values range from 0 (normal) to 63 (extreme depression). Mean Change = (Week 2 Mean Score - Baseline Mean Score).
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 |
What the finished NCT01909011 record still lists
NCT01909011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 82-participant average among 14 other Bipolar II Disorder trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Bipolar II Disorder appearing as the primary indexed condition, and to 2 interventions - of which Active CES is the first listed.
NCT01909011 reports a single indexed study location in New York.
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: Bipolar II Disorder.
What interventions are being tested in trial NCT01909011?
The interventions under investigation include: Active CES (DEVICE), Sham CES (DEVICE).
Who is sponsoring clinical trial NCT01909011?
This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Bipolar II Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01909011's enrollment target sits among peer trials
16 12th of 14 higher than 3 of 14 other Bipolar II Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar II Disorder 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
-
Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression
RECRUITING · NA
-
Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression
ACTIVE NOT RECRUITING · NA
-
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
RECRUITING · Phase 2
-
A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
RECRUITING · Phase 2
-
Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality
RECRUITING · Phase 2
-
Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia