NCT01322113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 26, 2013

Status Verified

March 1, 2011

Enrollment Period

2.3 years

First QC Date

March 23, 2011

Last Update Submit

September 25, 2013

Conditions

BIPOLAR DISORDER

Keywords

BIPOLARMANIADEPRESSION

Study Arms (1)

Na+, K+-ATPase/DLC system in BD

Bipolar patients in the various phases of the disease.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ALL BIPOLAR PATIENTS IN THE HADASSAH MEDICAL ORGANIZATION PSYCHIATRIC OUTPATIENTS CLINIC

You may qualify if:

  • BIPOLAR DISORDER PATIENTS

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

30 cc of pperipheral blood will be taken every 4 months to determine circulating DLC levels in patients

MeSH Terms

Conditions

Bipolar DisorderManiaDepression

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • RENA COOPER-KAZAZ, DR

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 26, 2013

Record last verified: 2011-03

Locations

IL(1)