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Nexalin Therapy for the Treatment of Depressive Symptoms

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ClinicalTrials.gov Identifier: NCT00774813
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Depression Device: Nexalin 1.3mA Device Device: Nexalin 15mA device Drug: placebo device and Citalopram Phase 2

Detailed Description:

This randomized, double-blind, placebo-controlled, multi-center trial has 3 different treatment arms.

Study Tools:

  • Hamilton Depression Rating Scale (HAM-D21)
  • Clinical Global Impressions (CGI)
  • Montgomery-Asberg Depression Rating Scale (MADRS)
  • Beck's Depression Inventory
  • Hamilton Anxiety Rating Scale (HAM-A)
  • Hospital Anxiety and Depression Scale (HADS)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study Using Nexalin Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depression Episodes
Study Start Date : October 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008
Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Nexalin 1.3mA device + placebo antidepressant
Device: Nexalin 1.3mA Device
  • 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
  • Daily receipt of placebo antidepressant
Other Name: Nexalin Device
Active Comparator: B
Nexalin 15mA device + 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
Other Name: Nexalin Device
Placebo Comparator: C
Placebo device + SSRI (Citalopram or similar)
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)
Other Name: Nexalin Device


Outcome Measures

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (HAM-D21) [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ]

Secondary Outcome Measures :
  1. Clinical Global Impression (CGI) [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ]
  2. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ]
  3. Beck's Depression Inventory [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ]
  4. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ]
  5. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ]
  6. Medication Usage Log [ Time Frame: Every visit ]
  7. Adverse Event Log [ Time Frame: Every visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774813


Locations
Russian Federation
Leningrad Regional Center of Addiction
Leningrad, Vsevolozhsky District, Russian Federation, 188661
St. Petersburg City Center of Neuroses
St. Petersburg, Russian Federation, 191187
Sponsors and Collaborators
Kalaco Scientific, Inc.
Investigators
Principal Investigator: Evgeny Kruptisky, MD, PhD Leningrad Regional Center of Addiction
More Information

Responsible Party: Evgeny Kruptisky, MD, PhD, Leningrad Regional Center of Addiction
ClinicalTrials.gov Identifier: NCT00774813     History of Changes
Other Study ID Numbers: CPMS-7003
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008

Keywords provided by Kalaco Scientific, Inc.:
Depression
Mild
Moderate
Anxiety
Kalaco Scientific, Inc.

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents