Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients
NCT ID: NCT00870311
Last Updated: 2009-03-27
Study Results
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Basic Information
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COMPLETED
PHASE4
28 participants
INTERVENTIONAL
1996-03-31
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
SINGLE
Study Groups
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Blinded Lithium
Bipolar Disorder patients
Lithium Carbonate
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.
Interventions
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Lithium Carbonate
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Wayne State University
OTHER
Responsible Party
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Wayne State University and National Institute of Mental Health
Principal Investigators
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Husseini K Manji, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University, National Institute of Mental Health
Debra A Glitz, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Gregory J Moore, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
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Wayne State University School of Medicine
Detroit, Michigan, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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NIMH (MH159107)
Identifier Type: -
Identifier Source: secondary_id
H12-48-95
Identifier Type: -
Identifier Source: org_study_id
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