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Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder (NA\K-MANIA)

This study has been completed.
Information provided by:
Hadassah Medical Organization Identifier:
First received: March 23, 2011
Last updated: September 25, 2013
Last verified: March 2011
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.


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples Without DNA
30 cc of pperipheral blood will be taken every 4 months to determine circulating DLC levels in patients

Enrollment: 30
Study Start Date: May 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Na+, K+-ATPase/DLC system in BD
Bipolar patients in the various phases of the disease.

Detailed 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;

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:


Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01322113

Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: RENA COOPER-KAZAZ, DR Hadassah Medical Organization
  More Information

Responsible Party: DR RENA COOPER-KAZAZ, Hadassah Medical Organization Identifier: NCT01322113     History of Changes
Other Study ID Numbers: NA/K PUMP-MANIA-HMO-CTIL
Study First Received: March 23, 2011
Last Updated: September 25, 2013

Keywords provided by Hadassah Medical Organization:

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders processed this record on May 25, 2017