Longitudinal Study on the Neuroprotective and Neurotrophic Effects of Lithium
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Bipolar Depression
Intervention: Lithium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s): Rodrigo Machado-Vieira, MD, PhD, Principal Investigator, Affiliation: Institute and Department of Psychiatry, University of Sao Paulo, Brazil
Summary
Thirty subjects with a DSM-IV (Diagnostic and Statistical Manual, fourth version)diagnosis
of BPD during a depressive or hypomanic episode will be divided in two groups according to
age and time of illness. All patients will receive lithium (flexible therapeutic dose) for 6
weeks and improvement will be evaluated weekly using depression and mania rating scales;
this study also objectives to identify state/trait markers and predictors of response.
Clinical Details
Official title: Longitudinal Study on the Neuroprotective and Neurotrophic Effects of Lithium in Bipolar Disorder: Identification of Cellular and Molecular Targets Clinically Relevant
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hamilton Depression Rating Scale (HAM-D)
Secondary outcome: Montgomery Asberg Depression Rating Scale (MADRS)
Detailed description:
Mood disorders are the most prevalent psychiatric, presenting chronic course and high
morbidity, affecting 10-15% of population. Diverse structural, functional and biochemical
cerebral changes described in the pathophysiology of mood disorders, in special Bipolar
Disorder (BPD), have been associated with impairments in neuroprotective mechanisms and
cellular resilience. However, the clinical relevance of these pathophysiological findings
have been rarely addressed. Meanwhile, lithium has been considered the most used mood
stabilizer worldwide, showing significant efficacy in the treatment of manic and depressive
episodes, as well as in the prevention of suicide and maintenance. Several studies have
demonstrated significant neuroprotective and neurotrophic effects induced by lithium
treatment in diverse cellular and molecular targets, but again, few is known about the
potential association between these cerebral effects and the its therapeutic clinical
efficacy induced by this proof of concept agent. The present project aims to investigate
brain levels of lithium using magnetic resonance spectroscopy (7Li-MRS) and its association
with different markers of neuronal viability such as n-acetyl-aspartate (using
1-hydrogen-MRS), as well as peripheral markers of mitochondrial, endoplasmic reticulum and
neurotrophic factors activity, all highly implicated in the pathophysiology of BD. The
investigator has been working in this area in the last ten years, in which the last three
and a half in the Lab of Molecular Pathophysiology and Experimental Therapeutics, National
Institute of Mental Health (NIMH), National Institutes of Health. The candidate is looking
forward to establish appropriate structure to develop a "Research Center for the Study of
Neuroplasticity and Neuroprotection in Psychiatric Disorders" in the Institute of
Psychiatry, University of Sao Paulo, Brazil. Overall, the study on the
neuroplasticity-mediated pathophysiological basis of BPD implicated in the clinical
presentation and outcome may shed light on the development of new, improved therapeutics for
this and other devastating psychiatric disorders.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- outpatients
- 18-45 yo
- DSM-IV diagnosis of bipolar disorder (BD-I or BD-II)
- current depressive episode based on the Structured Clinical Interview for the
Diagnostic and Statistical Manual for Mental Disorders(SCID-I)
- Hamilton Depression Rating Scale Score (HAM-D) ≥18
Exclusion Criteria
- Medical and psychiatric Comorbidity
- more than 5 years of disease duration
- presence of rapid cycling
Locations and Contacts
Institute of Psychiatry, University of Sao Paullo, Sao Paulo, SP 05410-000, Brazil
Additional Information
Starting date: September 2010
Last updated: August 6, 2013
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