CLE-100 as an Oral Therapy in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study
Summary
The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The objective of the study is to assess CLE-100 for the treatment of MDD in participants currently treated with standard antidepressant therapy.
Description
CLEO study is performed in two parts (part A and Part B). The sponsor is currently recruiting only for the Part A of the study.
Part A will be an inpatient study to assess the safety, tolerability, and pharmacokinetics of CLE-100 in MDD participants currently treated with an antidepressant drug. It will include a screening phase (up to 35 days), a 1 week inpatient double-blind treatment phase and an outpatient post treatment safety follow-up phase of 1 week after last study drug administration. The participants will remain on their current antidepressant therapy with no dose change during the study.
Study Design
Conditions
Adjunctive Treatment of Major Depressive Disorder
Intervention
CLE-100, placebo
Location
Hassman Research Institute, LLC
Marlton
New Jersey
United States
08053
Status
Recruiting
Source
Clexio Biosciences Ltd.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04103892
- ClinicalTrials.gov processed this data on September 30, 2019
Published on BioPortfolio: 2019-10-01T07:55:13-0400
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Medical and Biotech [MESH] Definitions
Bipolar Disorder
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
Depressive Disorder, Major
Marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation.
Trazodone
A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
Anhedonia
Inability to experience pleasure due to impairment or dysfunction of normal psychological and neurobiological mechanisms. It is a symptom of many PSYCHOTIC DISORDERS (e.g., DEPRESSIVE DISORDER, MAJOR; and SCHIZOPHRENIA).
Quetiapine Fumarate
A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.
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