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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01322113
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : September 26, 2013
Information provided by:
Hadassah Medical Organization

Brief 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.

Condition or 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;

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder
Study Start Date : May 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Digitalis

Na+, K+-ATPase/DLC system in BD
Bipolar patients in the various phases of the disease.

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

Information from the National Library of Medicine

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

Inclusion Criteria:


Exclusion Criteria:

  • NONE

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01322113

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Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: RENA COOPER-KAZAZ, DR Hadassah Medical Organization
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Responsible Party: DR RENA COOPER-KAZAZ, Hadassah Medical Organization Identifier: NCT01322113    
Other Study ID Numbers: NA/K PUMP-MANIA-HMO-CTIL
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: March 2011
Keywords provided by Hadassah Medical Organization:
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders