Ignite Creation Date:
2024-05-05 @ 9:24 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00879372
Status:
UNKNOWN
Last Update Posted:
2013-10-08
First Post:
2009-04-09
Brief Title:
Efficacy of Adjunctive Tianeptine in the Treatment of Bipolar Depression
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Double BlindRandomized Placebo Controlled Trial of Adjunctive Tianeptine in the Treatment of Bipolar Depression
Status:
UNKNOWN
Status Verified Date:
2013-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
One of the main challenges in the treatment of Bipolar Disorder BD is to achieve better functioning outcomes after syndromal recovery Even treatment-responsive patients who remain symptomatically well for extended periods of time frequently demonstrate sub-threshold symptoms and continuing psychosocial morbidity and cognitive impairment The cognitive impairment that persists during interepisode periods stands out as a major correlate of functional impairment and may be a core aspect of the BD pathophysiology
In this context tianeptine stands out as a therapeutic agent with unique properties which match most of the conditions found in BD
This is an enriched maintenance study of the use of tianeptine as an adjunctive therapy in bipolar depression All participants will receive tianeptine in an open label manner for a period of two months following which they will be assigned randomly to the treatment with tianeptine or placebo in a double-blind fashion for six months All patients will remain on treatment as usual for the duration of the trial Along with clinical response the investigators will prospectively evaluate the improvement in working and declarative memory two cognitive prefrontal- and hippocampus-dependent processes respectively and the effects of tianeptine on serum BDNF levels
In this context tianeptine stands out as a therapeutic agent with unique properties which match most of the conditions found in BD
This is an enriched maintenance study of the use of tianeptine as an adjunctive therapy in bipolar depression All participants will receive tianeptine in an open label manner for a period of two months following which they will be assigned randomly to the treatment with tianeptine or placebo in a double-blind fashion for six months All patients will remain on treatment as usual for the duration of the trial Along with clinical response the investigators will prospectively evaluate the improvement in working and declarative memory two cognitive prefrontal- and hippocampus-dependent processes respectively and the effects of tianeptine on serum BDNF levels
Detailed Description:
One of the main challenges in the treatment of Bipolar Disorder BD is to achieve better functioning outcomes after syndromal recovery Available treatments are reasonably effective in reducing acute symptoms but many times the syndromal recovery is not accompanied by the restoration of functioning capabilities This is particularly true for bipolar depression which is responsible for most of the burden associated with BD Even treatment-responsive patients who remain symptomatically well for extended periods of time frequently demonstrate sub-threshold symptoms and continuing psychosocial morbidity and cognitive impairment The cognitive impairment that persists during interepisode periods stands out as a major correlate of functional impairment and may be a core aspect of the BD pathophysiology Beyond that cognitive impairment worsens with cumulative episodes
Functional and morphometric studies have shown changes in amygdala hippocampus and prefrontal cortex of patients with bipolar disorder Effective treatments for bipolar disorder such as lithium and divalproex have proved to prevent cellular atrophy to have antiapoptotic properties and to increase BDNF levels Findings from neuropathological studies have confirmed reduction and dysgenesis of neuronal cell lines in the hippocampus in bipolar disorder Ultimately a main challenge in the treatment of BD is translating the knowledge of neuronal plasticity and neurobiology of the illness into novel therapeutic options
In this context tianeptine stands out as a therapeutic agent with unique properties which match most of the conditions found in BD The neurochemical properties of tianeptine vary from those of other tricyclic and non-tricyclic antidepressants Noteworthy none of current available medications for BD showed all these features 1 tianeptine exert opposite effects than chronic stress in neurons increasing neuroprotective factors what may help to quench the cycle of affective episode recurrence and neural and deterioration 2 tianeptine affects neuroplasticity in the hippocampus and have been reported to increase dendritic lengths 3 tianeptine increases BDNF levels in the amygdala 4 tianeptine attenuated stress-induced glutamate release in amygdala 5 tianeptine has anticonvulsant properties via adenosinergic A1 receptors 6 tianeptine has analgesic effects
In the present research project we plan on conducting an enriched maintenance study of the use of tianeptine as an adjunctive therapy in bipolar depression All participants will receive tianeptine in an open label manner for a period of two months following which they will be assigned randomly to the treatment with tianeptine or placebo in a double-blind fashion for six months All patients will remain on treatment as usual for the duration of the trial This trial will allow the investigation of the efficacy and tolerability of tianeptine 375mgday as an adjunctive treatment of bipolar depression and its impact on clinical variables associated with the aftermath of a bipolar depression episode Considering that tianeptine is approved to be used orally in humans and has been on the market for depression a low risk intervention using a novel approach may be provided by this clinical trial Along with clinical response we will prospectively evaluate the improvement in working and declarative memory two cognitive prefrontal- and hippocampus-dependent processes respectively and the effects of tianeptine on serum BDNF levels
Functional and morphometric studies have shown changes in amygdala hippocampus and prefrontal cortex of patients with bipolar disorder Effective treatments for bipolar disorder such as lithium and divalproex have proved to prevent cellular atrophy to have antiapoptotic properties and to increase BDNF levels Findings from neuropathological studies have confirmed reduction and dysgenesis of neuronal cell lines in the hippocampus in bipolar disorder Ultimately a main challenge in the treatment of BD is translating the knowledge of neuronal plasticity and neurobiology of the illness into novel therapeutic options
In this context tianeptine stands out as a therapeutic agent with unique properties which match most of the conditions found in BD The neurochemical properties of tianeptine vary from those of other tricyclic and non-tricyclic antidepressants Noteworthy none of current available medications for BD showed all these features 1 tianeptine exert opposite effects than chronic stress in neurons increasing neuroprotective factors what may help to quench the cycle of affective episode recurrence and neural and deterioration 2 tianeptine affects neuroplasticity in the hippocampus and have been reported to increase dendritic lengths 3 tianeptine increases BDNF levels in the amygdala 4 tianeptine attenuated stress-induced glutamate release in amygdala 5 tianeptine has anticonvulsant properties via adenosinergic A1 receptors 6 tianeptine has analgesic effects
In the present research project we plan on conducting an enriched maintenance study of the use of tianeptine as an adjunctive therapy in bipolar depression All participants will receive tianeptine in an open label manner for a period of two months following which they will be assigned randomly to the treatment with tianeptine or placebo in a double-blind fashion for six months All patients will remain on treatment as usual for the duration of the trial This trial will allow the investigation of the efficacy and tolerability of tianeptine 375mgday as an adjunctive treatment of bipolar depression and its impact on clinical variables associated with the aftermath of a bipolar depression episode Considering that tianeptine is approved to be used orally in humans and has been on the market for depression a low risk intervention using a novel approach may be provided by this clinical trial Along with clinical response we will prospectively evaluate the improvement in working and declarative memory two cognitive prefrontal- and hippocampus-dependent processes respectively and the effects of tianeptine on serum BDNF levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None