NCT00870311

Brief Summary

This study investigates the effects of Lithium treatment on signal transduction pathways, gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It is hypothesized that specific changes in these markers will correlate with lithium treatment responsiveness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 1996

Longer than P75 for phase_4

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

Study Start

First participant enrolled

March 1, 1996

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
Last Updated

March 27, 2009

Status Verified

March 1, 2009

Enrollment Period

8.1 years

First QC Date

March 25, 2009

Last Update Submit

March 25, 2009

Conditions

Bipolar Disorder

Keywords

LithiumNeuroprotectionNeurotrophicbcl2gsk3pkcMRImyoinositolMRSAlzheimers Disease

Outcome Measures

Primary Outcomes (1)

  • Brain myo-inositol levels

    4 weeks

Secondary Outcomes (3)

  • Signal transduction pathway measures

    4 weeks

  • Gene expression levels

    4 weeks

  • Brain volume

    4 weeks

Study Arms (1)

Blinded Lithium

EXPERIMENTAL

Bipolar Disorder patients

Drug: Lithium Carbonate

Interventions

Lithium CarbonateDRUG

300mg PO, three times daily with dose titrated to obtain a therapeutic plasma level of 0.8 to 1.2meq/L) over the first week of treatment. Total duration is a minimum of 3 weeks. Medication is dispensed in the form of blinded research capsules.

Also known as: Eskalith, Lithonate, Lithane, Lithotabs, Lithobid
Blinded Lithium

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet diagnostic criteria for Bipolar Mood Disorder determined by DSM-IV (SCID)

You may not qualify if:

  • Meeting criteria for any other DSM-IV axis I disorder
  • Psychoactive substance abuse or dependence within the past 1 year
  • Medical conditions placing patients at increased risk for lithium treatment (including renal disease, hepatic disease, hematological disease)
  • Devices/implants or conditions which preclude MRI investigation (including cardiac pacemaker/ICD, aneurysm clips, neurostimulator device, metallic fragments in or near the eye,claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

Location

Related Publications (5)

  • Chen G, Hasanat KA, Bebchuk JM, Moore GJ, Glitz D, Manji HK. Regulation of signal transduction pathways and gene expression by mood stabilizers and antidepressants. Psychosom Med. 1999 Sep-Oct;61(5):599-617. doi: 10.1097/00006842-199909000-00004.

    PMID: 10511011RESULT

  • Moore GJ, Bebchuk JM, Parrish JK, Faulk MW, Arfken CL, Strahl-Bevacqua J, Manji HK. Temporal dissociation between lithium-induced changes in frontal lobe myo-inositol and clinical response in manic-depressive illness. Am J Psychiatry. 1999 Dec;156(12):1902-8. doi: 10.1176/ajp.156.12.1902.

    PMID: 10588403RESULT

  • Moore GJ, Bebchuk JM, Hasanat K, Chen G, Seraji-Bozorgzad N, Wilds IB, Faulk MW, Koch S, Glitz DA, Jolkovsky L, Manji HK. Lithium increases N-acetyl-aspartate in the human brain: in vivo evidence in support of bcl-2's neurotrophic effects? Biol Psychiatry. 2000 Jul 1;48(1):1-8. doi: 10.1016/s0006-3223(00)00252-3.

    PMID: 10913502RESULT

  • Moore GJ, Bebchuk JM, Wilds IB, Chen G, Manji HK. Lithium-induced increase in human brain grey matter. Lancet. 2000 Oct 7;356(9237):1241-2. doi: 10.1016/s0140-6736(00)02793-8.

    PMID: 11072948RESULT

  • Moore GJ, Cortese BM, Glitz DA, Zajac-Benitez C, Quiroz JA, Uhde TW, Drevets WC, Manji HK. A longitudinal study of the effects of lithium treatment on prefrontal and subgenual prefrontal gray matter volume in treatment-responsive bipolar disorder patients. J Clin Psychiatry. 2009 Apr 21;70(5):699-705. doi: 10.4088/JCP.07m03745.

    PMID: 19389332DERIVED

MeSH Terms

Conditions

Bipolar DisorderFamilial paroxysmal dystoniaAlzheimer Disease

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium Compounds

Study Officials

  • Husseini K Manji, MD

    Wayne State University, National Institute of Mental Health

    PRINCIPAL INVESTIGATOR

  • Debra A Glitz, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR

  • Gregory J Moore, MD, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 27, 2009

Study Start

March 1, 1996

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

March 27, 2009

Record last verified: 2009-03

Locations

US(1)