Nexalin Therapy for the Treatment of Depressive Symptoms
NCT00774813 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2008-10-17
Summary
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
Interventions
- DEVICE
-
Nexalin 1.3mA Device
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of placebo antidepressant
- DEVICE
-
Nexalin 15mA device
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of a placebo antidepressant
- DRUG
-
placebo device and Citalopram
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of a a SSRI (Citalopram or similar)
Sponsors & Collaborators
-
Kalaco Scientific, Inc.
lead INDUSTRY
Principal Investigators
-
Evgeny Kruptisky, MD, PhD · Leningrad Regional Center of Addiction
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-10-31
- Primary Completion
- 2008-05-31
- Completion
- 2008-05-31
Countries
- Russia
Study Locations
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