Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608641
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double-blind Oral Multiple-dose Parallel Randomized Study to Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients with Acute Mania Episodes with or Without Mixed Features
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bipolar disorder BPD is a chronic debilitating illness characterized by drastic swings in mood energy and functional ability that affects the adult population Endoxifen is an active metabolite of the marketed drug Tamoxifen and the present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the Bipolar I disorder patient population compared to a placebo arm Endoxifen will be compared to a placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products Thus Endoxifen will be compared to placebo to demonstrate that the test product is safe and active
Detailed Description:
Protein Kinase C PKC plays a major role in the regulation of both pre and postsynaptic neurotransmission Excessive activation of PKC results in symptoms related to bipolar disorder PKC exists as a family of closely related subspecies has a heterogeneous distribution in the brain with particularly high levels in presynaptic nerve terminals and plays a crucial role in the regulation of neuronal excitability neurotransmitter release regulation of synaptic plasticity and various forms of learning and memory Research findings show that the PKC pathway can be used as a target for developing treatment strategies for bipolar disorder Endoxifen exhibited activity in inhibiting the PKC activity
In patients with acute bipolar mania rapid reduction of symptoms is a key treatment goal however there is also a need for effective maintenance of effect treatment beyond the period of acute stabilization The current study will evaluate the efficacy and safety of Endoxifen in Bipolar I Disorder patients against a control placebo arm
In patients with acute bipolar mania rapid reduction of symptoms is a key treatment goal however there is also a need for effective maintenance of effect treatment beyond the period of acute stabilization The current study will evaluate the efficacy and safety of Endoxifen in Bipolar I Disorder patients against a control placebo arm
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