Longitudinal Study on the Neuroprotective and Neurotrophic Effects of Lithium
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 10, 2013
CompletedFirst Posted
Study publicly available on registry
August 9, 2013
CompletedAugust 9, 2013
August 1, 2013
2.2 years
July 10, 2013
August 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale (HAM-D)
6 week
Secondary Outcomes (1)
Montgomery Asberg Depression Rating Scale (MADRS)
6 week
Other Outcomes (1)
Young Mania Rating Scale
6 week
Study Arms (1)
Lithium 450-900mg/day
EXPERIMENTALAn Open-Label, 6-week Pilot Study of Flexible Dose of Lithium in Bipolar Depression: The Effectiveness of Lower Lithium Levels
Interventions
Eligibility Criteria
You may qualify if:
- outpatients
- 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
You may not qualify if:
- Medical and psychiatric Comorbidity
- more than 5 years of disease duration
- presence of rapid cycling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Psychiatry, University of Sao Paullo
São Paulo, São Paulo, 05410-000, Brazil
Related Publications (1)
Zanetti MV, Otaduy MC, de Sousa RT, Gattaz WF, Busatto GF, Leite CC, Machado-Vieira R. Bimodal effect of lithium plasma levels on hippocampal glutamate concentrations in bipolar II depression: a pilot study. Int J Neuropsychopharmacol. 2014 Oct 31;18(6):pyu058. doi: 10.1093/ijnp/pyu058.
PMID: 25522399DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodrigo Machado-Vieira, MD, PhD
Institute and Department of Psychiatry, University of Sao Paulo, Brazil
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 10, 2013
First Posted
August 9, 2013
Study Start
September 1, 2010
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
August 9, 2013
Record last verified: 2013-08