DepressionPhase 2NCT00774813
Nexalin Therapy for the Treatment of Depressive Symptoms
A Phase 2 study testing Nexalin 1.3mA Device and Nexalin 15mA device in people with Depression, run by Kalaco Scientific, Inc. at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Nexalin 1.3mA Device and Nexalin 15mA device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesRussia
- Study dates
- Oct 2007to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Leningrad Regional Center of Addiction
Saint Petersburg, Vsevolozhsky District, 188661
St. Petersburg City Center of Neuroses
Saint Petersburg, 191187
About this study
Official title: Phase II Study Using Nexalin Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depression Episodes
The primary objectives of this Phase II study are to demonstrate the safety of Nexalin Therapy and to investigate the efficacy of Nexalin Therapy.
Read the 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)
- Conditions
- Depression
- Being tested
- Nexalin 1.3mA Device, Nexalin 15mA device, placebo device and Citalopram
- Keywords
- Depression, Mild, Moderate, Anxiety, Kalaco Scientific, Inc.
- Medical subject headings
- Depression, Lymphoma, Follicular, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexalin 1.3mA DeviceDevice
Also called Nexalin Device
- 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
- Daily receipt of placebo antidepressant
Nexalin 15mA deviceDevice
Also called Nexalin Device
- 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
- Daily receipt of a placebo antidepressant
placebo device and CitalopramDrug
Also called Nexalin Device
- 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off)
- Daily receipt of a a SSRI (Citalopram or similar)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Nexalin 1.3mA device + placebo antidepressant Receives: Device: Nexalin 1.3mA Device |
| B | Active comparator | Nexalin 15mA device + placebo antidepressant Receives: Device: Nexalin 15mA device |
| C | Placebo comparator | Placebo device + SSRI (Citalopram or similar) Receives: Drug: placebo device and Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D21)
Measured: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Secondary outcomes (7)
Clinical Global Impression (CGI)
Measured: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Beck's Depression Inventory
Measured: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Hamilton Anxiety Rating Scale (HAM-A)
Measured: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Hospital Anxiety and Depression Scale (HADS)
Measured: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Medication Usage Log
Measured: Every visit
Adverse Event Log
Measured: Every visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kalaco Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Evgeny Kruptisky, MD, PhD, Principal investigator, Leningrad Regional Center of Addiction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774813
- Sponsor's protocol ID
- CPMS-7003
- Status last verified
- Oct 2008
- First submitted
- 3 Jul 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Using Nexalin Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depression Episodes
- ClinicalTrials.gov ID
- NCT00774813
- Acronym / sponsor ID
- CPMS-7003
- Conditions
- Depression
- Keywords
- Depression, Mild, Moderate, Anxiety, Kalaco Scientific, Inc.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kalaco Scientific, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this Phase II study are to demonstrate the safety of Nexalin Therapy and to investigate the efficacy of Nexalin Therapy.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Nexalin 1.3mA DeviceNexalin 1.3mA device + placebo antidepressant |
| B | Active comparator | Device: Nexalin 15mA deviceNexalin 15mA device + placebo antidepressant |
| C | Placebo comparator | Drug: placebo device and CitalopramPlacebo device + SSRI (Citalopram or similar) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexalin 1.3mA DeviceAlso: Nexalin Device* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of placebo antidepressant | Device | A |
| Nexalin 15mA deviceAlso: Nexalin Device* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of a placebo antidepressant | Device | B |
| placebo device and CitalopramAlso: Nexalin Device* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of a a SSRI (Citalopram or similar) | Drug | C |
Primary outcome
Hamilton Depression Rating Scale (HAM-D21)
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
7 secondary outcomes
Clinical Global Impression (CGI)
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Beck's Depression Inventory
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Hospital Anxiety and Depression Scale (HADS)
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Medication Usage Log
Time frame: Every visit
Adverse Event Log
Time frame: Every visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgeny Kruptisky, MD, PhD principal investigator
Leningrad Regional Center of Addiction
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nexalin 1.3mA Device and Nexalin 15mA device in people with Depression, run by Kalaco Scientific, Inc. at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HAM-D21) (time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2008.