Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder

BIPOLAR DISORDER Clinical Trial

— NA\K-MANIA  

Official title:

Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322113
• Other study ID #: NA/K PUMP-MANIA-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: September 25, 2013
• Start date: May 2011
• Est. completion date: September 2013

Study information

• Verified date: March 2011
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: ISRAEL MINISTRY OF HEALTH DIRECTOR GENERAL, ISRAEL':'
• Study type: Observational

Clinical Trial Summary

This study deals with the possible molecular mechanisms that underlie the etiology of bipolar disorders (BD). Previous studies have implicated Na+, K+-ATPase and endogenous digitalis-like compounds (DLC) in the depressive state of this disease. The possibility, however, that they are also involved in the manic phase of the disease was never addressed. The results of this study may have significant implications for the treatment of BD by DLC derivatives.

Description:

Depressive symptoms are the hallmark major depressive disorder, dysthymia and bipolar depression within the context of bipolar disorder (BD). They share clinical characteristics including depressed mood, anhedonia, and low energy and require medical treatment. The Na+, K+-ATPase is a major transporter in the plasma membrane which has an important role in regulating cell volume, cytoplasmic pH and Ca++ levels. Digitalis-like compounds (DLC); steroids identified as normal constituents of human brain, plasma and other tissues, exclusively interact with the Na+, K+-ATPase and induce numerous biological effects. We raised the hypothesis that Na+, K+-ATPase/DLC system is involved in BD based on studies from ours and other laboratories, which tested the involvement of this system in the depressive state of BD. The possibility that the interaction of DLC with the Na+, K+-ATPase is involved in the manic state of BD was scarcely investigated. To address this issue we intend to determine circulating DLC levels in patients with BD at different states of the disease;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• BIPOLAR DISORDER PATIENTS

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• BIPOLAR DISORDER

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel,