An interventional study of Alpha-Stim Active and Alpha-Stim Inactive in Anxiety and Depression, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-19.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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Among 81 studies in Depression by University of California, Los Angeles — 12 open to participants now, 12 under way, none of them phase 3. Depression · University of California, Los Angeles.
Among the 81 studies in Depression by University of California, Los Angeles, this one is the 51st largest by enrollment of the 74 interventional ones that give a count, is one of 5 that started in 2016, is one of 45 with no phase, and was the 39th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →12 of the 81 studies in Depression by University of California, Los Angeles are open now, in 1 country. Recruiting first, the newest first:
University of California, Los Angeles · Sites in United States
Ages 50–95
University of California, Los Angeles · Sites in United States
Ages 18+ · Women only
University of California, Los Angeles · Sites in United States
Ages 18+ · Women only · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18+
University of California, Los Angeles · Sites in United States
Ages 18–65
By country, each count listing its studies:
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years to 40 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
81 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 7 · Phase 3 1 · Phase 4 14
First in 2001; this study’s year is marked. 5 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 44 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 76 across the 74 interventional studies, 1,490 across the 5 observational. Of the 64 that completed or were terminated, 14 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
3 of the studies in Depression by University of California, Los Angeles that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05591937University of California, Los AngelesS.T.A.N.D. Alacrity Center Signature Project | 2027-04-30 |
| NCT07577947University of California, Los AngelesHealth And Response: Digital Markers for Outcomes in Perinatal Depression Treatment Study | 2027-05-01 |
| NCT07219875University of California, Los AngelesTraining Reward Responsiveness Through Virtual Reality | 2027-06 |
Add all 3 to your calendar (.ics) → With an account.
Among the 81 studies in Depression by University of California, Los Angeles, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The investigators aim to use a CES (cranial electrotherapy stimulation) intervention to improve emotional well-being by reducing symptoms of anxiety and depression and to assess for changes in markers of cellular health - specifically, telomere length and telomerase activity
This study aims to test an auricular cranial electrotherapy stimulation (CES) device, Alpha-Stim, to assess for changes in markers of cellular health and emotional well-being improvement associated with anxiety and depression.
Returning Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) Veterans have a high incidence of anxiety, depression, insomnia, post-traumatic stress disorder (PTSD) and chronic pain, leading to reductions in emotional well-being. This type of chronic emotional distress can lead to detrimental biological outcomes. We will compare as an exploratory outcome Veterans vs. non-Veterans response to Alpha-Stim treatment. At the cellular level, impairment of the telomere/telomerase system may be a result of this dysregulation, given the descriptions of shorter telomeres (a marker of cellular aging), as well as increased markers of inflammation in subjects with depression, anxiety and PTSD, compared to aged matched healthy populations. These negative cellular effects of emotional distress have not been well studied in this population and may offer significant benefit.
In one study of auricular CES using the same protocol proposed here, 115 patients with anxiety or anxiety and comorbid depression were studied over 5 weeks in a randomized, sham controlled trial, showing significant improvements in both anxiety and depression symptoms. Due to the complexity of overlapping negative affect symptoms that lead to impaired emotional well-being in Veterans, the investigators chose in this proposal to evaluate a composite measure of emotional distress (a combined anxiety and depression score) as the primary outcome. Beyond depression and anxiety, CES has been associated with reductions in insomnia and pain, both of which are also significant problems in Veterans, likely contributing to reduced emotional well-being.
Primarily all interested and appropriate study subjects will undergo a screening at the University of California, Los Angeles (UCLA) G. Oppenheimer Center for Neurobiology of Stress and Resilience (CNSR). The investigators expect to enroll and screen no less than 55 subjects in order to complete 22 evaluable subjects for analysis in each treatment group.
The Hospital Anxiety and Depression Scale (HADS) will assess symptom severity defined as normal range (0-7), mild (8-10), moderate (11-14) or severe (15-20). Subjects with impaired emotional well-being with mild to moderate anxiety and/or depression on the HADS scale will be included. Subjects with a maximum combined HADS score of 28 will be included. Subjects treated for anxiety, depression, psychiatric or mental health treatment must be on a stable regimen (pharmacological or non-pharmacological) for the past 3 months.
If eligible the study coordinator will contact them to schedule a screening visit at UCLA. During this visit, the research team will conduct baseline measurements via study questionnaires, history and physical exam, and a standardized psychiatric evaluation (MINI). Subjects meeting the inclusion criteria will have training in use of the Alpha-Stim device and will have their first 1 hour treatment. Subjects who tolerate the CES treatment will have blood drawn for biological measures and will take the device home to use daily for 8 weeks. Mid-study the subjects will come back to UCLA to complete questionnaires and have vital signs and weight measured. At the end of the 8 weeks, subjects will return to UCLA, return the device, have vital signs and weight measured, have the final blood draw, and complete a final set of questionnaires.
All in all, to complete the study, subjects will have an initial screening, mid and final study visit, pre, mid, and final study questionnaires, and blood drawn in the first and final visit.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
This study's enrollment of 44 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Browse Depression studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Device: Alpha-Stim Active
Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive "treatment" one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.
Device: Alpha-Stim Inactive
The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia
The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive.
HADS Questionnaire Combined Score
The Hospital anxiety and depression scale (HADS) evaluates symptoms of anxiety and depression, minimum 0 and maximum 52 with higher scores indicating more symptoms. A combined score it utilized as the primary outcome measure, summing the scores for anxiety and depression.
Time frame: After completion of the study (1 year)
Telomere Length
Telomere length will be determined using real time quantitative polymerase chain reaction (qPCR) methodology as described previously with minor modifications.30,31 Peripheral blood mononuclear cells (PBMC) are isolated and genomic DNA extracted. Using the standard curve method, cycle threshold (CT) values are plotted on a standard curve of human genomic DNA to estimate an ng/microliter concentration value. Telomere length values are expressed as the ratio of the estimated concentration generated by PCR of the telomere gene (T) divided by the hemoglobin single (S) copy gene = (T/S).
Time frame: After completion of the study (1 year)
Subjects were recruited by flyers from the WLA VA Integrative Medicine Clinics and on the UCLA campus between April 2016 and August 2018.
| Milestone | Active | Inactive |
|---|---|---|
| Started | 16 | 14 |
| Completed | 13 | 11 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 3 | 3 |
The Hospital anxiety and depression scale (HADS) evaluates symptoms of anxiety and depression, minimum 0 and maximum 52 with higher scores indicating more symptoms. A combined score it utilized as the primary outcome measure, summing the scores for anxiety and depression.
| score on a scale | Active | Inactive |
|---|---|---|
| Baseline estimated means | 20.3077 ± 1.65 | 19.909 ± 1.79 |
| Post treatment estimated mean | 11.1538 ± 1.65 | 15.4545 ± 1.79 |
Telomere length will be determined using real time quantitative polymerase chain reaction (qPCR) methodology as described previously with minor modifications.30,31 Peripheral blood mononuclear cells (PBMC) are isolated and genomic DNA extracted. Using the standard curve method, cycle threshold (CT) values are plotted on a standard curve of human genomic DNA to estimate an ng/microliter concentration value. Telomere length values are expressed as the ratio of the estimated concentration generated by PCR of the telomere gene (T) divided by the hemoglobin single (S) copy gene = (T/S).
| T/S | Active | Inactive |
|---|---|---|
| Telomere Length | .6945 ± .03231 | .7841 ± .03487 |
Collected over Adverse events were collected during the study period (10 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | 0/13 (0%) | 0/13 (0%) | 2/13 (15.4%) |
| Inactive | 0/11 (0%) | 0/11 (0%) | 6/11 (54.5%) |
| Event | Active | Inactive |
|---|---|---|
| increased irritabilityPsychiatric disorders | 0/13 | 1/11 |
| upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 0/13 | 1/11 |
| vitamin d deficiencyEndocrine disorders | 0/13 | 1/11 |
| headahceNervous system disorders | 0/13 | 1/11 |
| panic attackPsychiatric disorders | 0/13 | 1/11 |
| insomniaGeneral disorders | 0/13 | 1/11 |
| fatigueGeneral disorders | 1/13 | 0/11 |
| ear infectionEar and labyrinth disorders | 1/13 | 0/11 |
| Age, Continuous(years) | Active | Inactive | Total |
|---|---|---|---|
| Mean | 28.62 ± 7.29 | 27.09 ± 5.72 | 27.92 ± 6.52 |
| Sex: Female, Male(Participants) | Active | Inactive | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 13 | 11 | 24 |
| Race (NIH/OMB)(Participants) | Active | Inactive | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 7 | 5 | 12 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 2 | 3 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Mar 2016, a primary completion of Oct 2018 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2020, 1 year 9 months after primary completion. A results delay was requested in Oct 2019.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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