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Nexalin Therapy for the Treatment of Depressive Symptoms

This study has been completed.
Sponsor:
Information provided by:
Kalaco Scientific, Inc.
ClinicalTrials.gov Identifier:
NCT00774813
First received: July 3, 2008
Last updated: October 16, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Intervention Phase
Depression
 Device: Nexalin 1.3mA Device
Device: Nexalin 15mA device
Drug: placebo device and Citalopram
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kalaco Scientific, Inc.:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HAM-D21) [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression (CGI) [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ] [ Designated as safety issue: No ]
  • Beck's Depression Inventory [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12 ] [ Designated as safety issue: No ]
  • Medication Usage Log [ Time Frame: Every visit ] [ Designated as safety issue: No ]
  • Adverse Event Log [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: October 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Evgeny Kruptisky, MD, PhD, Leningrad Regional Center of Addiction
ClinicalTrials.gov Identifier: NCT00774813     History of Changes
Other Study ID Numbers: CPMS-7003
Study First Received: July 3, 2008
Last Updated: October 16, 2008
Health Authority: United States: Institutional Review Board
Russia: Ministry of Health of the Russian Federation

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 21, 2013