Clinical trial · Interventional
Nexalin Therapy for the Treatment of Depressive Symptoms
Phase II Study Using Nexalin Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depression Episodes
NCT00774813CI-TRIAL-00001735completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objectives of this Phase II study are to demonstrate the safety of Nexalin Therapy and to investigate the efficacy of Nexalin Therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nexalin 1.3mA Device | Device | — | UNRESOLVED |
| Nexalin 15mA device | Device | — | UNRESOLVED |
| placebo device and Citalopram | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Nexalin 1.3mA device + placebo antidepressant
- interventionNames
- Device: Nexalin 1.3mA Device
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Nexalin 15mA device + placebo antidepressant
- interventionNames
- Device: Nexalin 15mA device
- type
- PLACEBO_COMPARATOR
- label
- C
- description
- Placebo device + SSRI (Citalopram or similar)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with mild to moderate depression episode, based on the HAM-D21 Rating Scale (10-13 = mild; 14-17 = mild to moderate) * Diagnosed with mild to moderate depression episode based on ICD-10 Diagnostic Guidelines * Is willing and able to spend 4 weeks as a hospital inpatient * Is willing and able to return to the clinic during follow-up period Exclusion Criteria: * A HAM-D21 Rating Scale of \<10 or \>17 * Diagnosed outside of mild to moderate depression episode range based on the ICD-10 Diagnostic Guidelines * Unable to complete wash-out interval without taking antidepressants or psychotropic medications * Is pregnant or may be pregnant * Sensitivity to electrodes and/or their conductive gels or adhesives * Break in skin integrity at the areas of electrode placement * Currently taking immune suppressing drugs or suspected use of narcotics * Presence of any implanted electronic devices, cardiac stimulator, or pacemaker * History of brain injury, including seizures, epilepsy, stroke, tumor of central nervous system, or hydrocephalus * History of heart attacks, congestive heart failure, or uncontrolled hypertension * History of schizophrenia or manic-depressive syndrome
References
Publications (0)
Data not yet available
No reference posted for this study.