Indirect Evaluation of Lithium Level in Blood Using Non-invasive Sweat Biosensors

NCT04186507 | Unknown DMC FDA Drug

• 1 other identifier: TiratCarmelMHC
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Indirect evaluation of the accuracy and the efficacy of biosensors developed for Li+ detection in sweat.

Conditions

Lithium Level Detection in Sweat

Keywords

Lithium; Biosensor; Sweat; Major Depressive Disorder; Schizoaffective Disorder; Bipolar Mood Disorder; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Lithium sweat concentration

  Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD) will be placed on the right wrist of each participant for a non-invasive measurement of blood Li+ level.

  6 month

Study Arms (2)

Prelaminary group

To confirm that Li+ is detectable in sweat .

Spectrophon LTD biosensors for Li+ detection in sweat

In this group will be conducted to estimate the suitability, efficacy and accuracy of developed biosensors for non-invasive detection of Li+ in sweat

Combination Product: Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD)

Interventions

Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD) COMBINATION_PRODUCT

To confirm that Li+ is detectable in sweat using Macroduct Sweat Collection System for sweat collection. Current studies demonstrate that Li+ can be detected in saliva and in sweat. To confirm it, patients that are on treatment with Li+ will be recruited for this aim; sweat will be collected and checked for Li+ levels. To develop the algorithm for Spectrophon LTD biosensors for Li+ levels measurement in sweat that will allow assessing the level of Li+ in blood. To evaluate the accuracy and the efficacy of biosensors developed by Spectrophon LTD for Li+ detection in sweat. Following positive results in previous objectives, clinical trial will be conducted to estimate the suitability, efficacy and accuracy of developed biosensors for non-invasive detection of Li+ in sweat.

Also known as: Drug: Lithium

Spectrophon LTD biosensors for Li+ detection in sweat

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Psychiatric Inpatients with MDD, BMD, Schizoaffective Disorder, Schizophrenia.

You may qualify if:

• Meeting Diagnostic and Statistical Manual 5th edition (DSM-V) criteria for MDD, BMD, Schizoaffective Disorder, Schizophrenia;
• Patients must be on constant Li+ treatment or prior their first drug administration.
• Ability and willingness to sign an informed consent form for participation in the study.

You may not qualify if:

• Evidence of serious disorder;
• Unstable chronic disease;
• Kidney disease
• Pregnancy;
• Contraindication for Li+ treatment.

Sponsors & Collaborators

• Tirat Carmel Mental Health Center: lead
• Ariel University: collaborator

Study Sites (1)

Tirat Carmel Mental Health Center

Tirat Carmel, Haifa District, 30200, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Psychotic Disorders; Bipolar Disorder; Schizophrenia

Interventions

Lithium

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Psychiatric Department , Clinical Assistant Professor Anatoly Kreinin, MD, PHD, MHA

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: January 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: July 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

IL (1)