Major Depressive Disorder Clinical Trial
Official title:
An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg
NCT number | NCT00463242 |
Other study ID # | CAGO178A2303 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 2007 |
Verified date | May 2012 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.
Status | Completed |
Enrollment | 501 |
Est. completion date | |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Male and female adults, 18 through 70 years of age, inclusive - Diagnosis of Major Depressive Disorder according to DSM-IV criteria - HAM-D17 total score > or = 22 at Screening and Baseline Exclusion Criteria: - History of non-response to paroxetine - Patients who have been previously treated with agomelatine - History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder - Any current Axis I disorder other than major depressive disorder which is the focus of treatment - Substance or alcohol abuse in the last 30 days, dependence in the last 6 months - Use of any psychoactive medication after the screening visit - Female patients of childbearing potential who are not using effective contraception Other protocol-defined inclusion/exclusion criteria may apply |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Novartis Investigative Site | Hato Rey | |
United States | Novartis Investigative Site | Augusta | Georgia |
United States | Novartis Investigative Site | Austin | Texas |
United States | Novartis Investigative Site | Baltimore | Maryland |
United States | Novartis Investigative Site | Baltimore | Maryland |
United States | Novartis Investigative Site | Bellevue | Washington |
United States | Novartis Investigative Site | Boca Raton | Florida |
United States | Novartis Investigative Site | Canton | Ohio |
United States | Novartis Investigative Site | Charlotte | North Carolina |
United States | Novartis Investigative Site | Colorado Springs | Colorado |
United States | Novartis Investigative Site | Corvallis | Oregon |
United States | Novartis Investigative Site | Dallas | Texas |
United States | Novartis Investigative Site | Durham | North Carolina |
United States | Novartis Investigative Site | Erie | Pennsylvania |
United States | Novartis Investigative Site | Fall River | Massachusetts |
United States | Novartis Investigative Site | Fort Myers | Florida |
United States | Novartis Investigative Site | Friendswood | Texas |
United States | Novartis Investigative Site | Herndon | Virginia |
United States | Novartis Investigative Site | Honolulu | Hawaii |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Jacksonville | Florida |
United States | Novartis Investigative Site | Jacksonville | Florida |
United States | Novartis Investigative Site | Joliet | Illinois |
United States | Novartis Investigative Site | Lincoln | Nebraska |
United States | Novartis Investigative Site | Media | Pennsylvania |
United States | Novartis Investigative Site | Miami | Florida |
United States | Novartis Investigative Site | National City | California |
United States | Novartis Investigative Site | New York | New York |
United States | Novartis Investigative Site | Okemos | Michigan |
United States | Novartis Investigative Site | Orange | California |
United States | Novartis Investigative Site | Orlando | Florida |
United States | Novartis Investigative Site | Overland Park | Kansas |
United States | Novartis Investigative Site | Pasadena | California |
United States | Novartis Investigative Site | Philadelphia | Pennsylvania |
United States | Novartis Investigative Site | Phoenix | Arizona |
United States | Novartis Investigative Site | Pico Rivera | California |
United States | Novartis Investigative Site | Redlands | California |
United States | Novartis Investigative Site | Richmond | Virginia |
United States | Novartis Investigative Site | Rockville | Maryland |
United States | Novartis Investigative Site | Saint Charles | Missouri |
United States | Novartis Investigative Site | Saint Louis | Missouri |
United States | Novartis Investigative Site | San Diego | California |
United States | Novartis Investigative Site | San Diego | California |
United States | Novartis Investigative Site | Torrance | California |
United States | Novartis Investigative Site | Waukesha | Wisconsin |
United States | Novartis Investigative Site | Willingboro | New Jersey |
United States | Novartis Investigative Site | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Novartis |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale | 8 weeks | ||
Secondary | To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX). | 8 weeks | ||
Secondary | Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8. | 8 weeks | ||
Secondary | Proportion of patients with MDD who achieve remission, | 8 weeks | ||
Secondary | Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD). | 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 |