Nexalin Therapy for the Treatment of Depressive Symptoms

NCT00774813 | Completed Phase 2

• 1 other identifier: CPMS-7003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Keywords

Depression; Mild; Moderate; Anxiety; Kalaco Scientific, Inc.

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HAM-D21)

  Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12

Secondary Outcomes (7)

• Clinical Global Impression (CGI)

  Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12

• Beck's Depression Inventory

  Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12

• Hamilton Anxiety Rating Scale (HAM-A)

  Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12

• Hospital Anxiety and Depression Scale (HADS)

  Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12

Study Arms (3)

A

ACTIVE COMPARATOR

Nexalin 1.3mA device + placebo antidepressant

Device: Nexalin 1.3mA Device

B

ACTIVE COMPARATOR

Nexalin 15mA device + placebo antidepressant

Device: Nexalin 15mA device

C

PLACEBO COMPARATOR

Placebo device + SSRI (Citalopram or similar)

Drug: placebo device and Citalopram

Interventions

Nexalin 1.3mA Device DEVICE

* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of placebo antidepressant

Also known as: Nexalin Device

A

Nexalin 15mA device DEVICE

* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of a placebo antidepressant

Also known as: Nexalin Device

B

placebo device and Citalopram DRUG

* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of a a SSRI (Citalopram or similar)

Also known as: Nexalin Device

C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kalaco Scientific, Inc.: lead

Study Sites (2)

Leningrad Regional Center of Addiction

Saint Petersburg, Vsevolozhsky District, 188661, Russia

Location

St. Petersburg City Center of Neuroses

Saint Petersburg, 191187, Russia

Location

MeSH Terms

Conditions

Depression; Lymphoma, Follicular; Anxiety Disorders

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Evgeny Kruptisky, MD, PhD

  Leningrad Regional Center of Addiction

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: October 17, 2008
• Study Start: October 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 17, 2008

Record last verified: 2008-10

Locations

RU (2)