Clinical trial NCT01543724: Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder
Official title: A Multimodal Brain Imaging Study to Investigate Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder: Glycogen Synthase Kinase 3β Single Nucleotide Polymorphisms and Gray Matter Volume Increase Following Lithium Treatment in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Lithium
Bipolar disorder
Multimodal Brain Imaging
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
Collaborators: name: Soon Chun Hyang University
First posted: 2012-03-05
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will assess Li-induced gray matter volume changes with regard to the endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more attributable to neurotrophic and neuroprotective characteristics of Li, which were closely related to the inhibition of apoptotic activity of GSK3beta.


Eligibility criteria: Inclusion Criteria:

* Men and Women aged between 19 and 55
* Diagnosis of bipolar I disorder as assessed by the structured clinical interview for DSM-IV (SCID-IV)
* Patients who have not used psychoactive medications for more than 2 weeks
* Individuals who provided written consent for participation

Exclusion Criteria:

* Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.)
* Women who are pregnant, breastfeeding, or planning pregnancy
* Diagnosis of any Axis I disorder other than bipolar disorder
* Intelligence quotient below 80
* Current or past drug abuse
* Contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.)

Primary outcomes:
measure: Change from baseline in manic symptom scores at 12 weeks
timeFrame: Baseline and at 12 weeks
measure: Change from baseline in manic symptom scores at 8 weeks
timeFrame: Baseline and at 8 weeks
measure: Change from baseline in manic symptom scores at 4 weeks
timeFrame: Baseline and at 4 weeks
measure: Change from baseline in manic symptom scores at 1 week
timeFrame: Baseline and at 1 week
measure: Change from baseline in depressive symptom scores at 12 weeks
timeFrame: Baseline and at 12 weeks
measure: Change from baseline in depressive symptom scores at 8 weeks
timeFrame: Baseline and at 8 weeks
measure: Change from baseline in depressive symptom scores at 4 weeks
timeFrame: Baseline and at 4 weeks
measure: Change from baseline in depressive symptom scores at 1 week
timeFrame: Baseline and at 1 week
measure: Change from baseline in global function scores at 12 weeks
timeFrame: Baseline and at 12 weeks
measure: Change from baseline in global function scores at 8 weeks
timeFrame: Baseline and at 8 weeks
measure: Change from baseline in global function scores at 4 weeks
timeFrame: Baseline and at 4 weeks
measure: Change from baseline in global function scores at 1 week
timeFrame: Baseline and at 1 week
Secondary outcomes:
measure: Changes from baseline in brain structure analyzed using computational approach
timeFrame: Baseline and at 12 weeks
measure: Number of participants with adverse events
timeFrame: 12 weeks
measure: Number of participants with adverse events
timeFrame: 8 weeks
measure: Number of participants with adverse events
timeFrame: 4 weeks
measure: Number of participants with adverse events
timeFrame: 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: