Novartis Pharmaceuticals is sponsoring a clinical research trial for males and females, at least 18 years of age and no older than 65 years with treatment-resistant depression.
Treatment-resistant depression describes a condition in which people with major depressive disorder do not see improvement in their depression symptoms from at least two different antidepressants for a period longer than 8 weeks at a dose which is greater than the lowest recommended dose.
Treatment-resistant depression is common. About one third of those with major depressive disorder have symptoms that don’t respond to treatment.
To learn more about treatment-resistant depression, click here.
This study is designed to look at how the study drug affects patients with treatment-resistant depression. The effects of the study drug will be compared to placebo effects. A placebo is a dummy substance with no active medicine. The placebo is used to make sure that the changes you experience are not happening just by chance.
If you agree to participate in this study, there will be a screening period where certain tests will be done to see if you qualify for the study. If your results show that you are qualified, you will be randomized to receive either the study drug or a placebo. Being ‘randomized’ means that you are put into either the study drug or placebo group by chance, and neither you nor your study doctor can choose which group you will be in. However, your study doctor can find out which medication you are taking if there is an emergency.
In total, the study will last for up to 14 weeks. This includes a 4-week screening and initial period of testing to determine eligibility, a 5-week treatment period, and a 5-week follow-up period.
To see if you may be eligible, click here to complete a pre-screener.
Find out if there is a treatment-resistant depression clinical study location nearby.
Patients who participate in this trial must meet the following requirements:
At least 18 years of age and no older than 65 years
Diagnosed with clinical depression
Had at least two treatments for depression that didn’t improve their condition
Aren’t currently abusing alcohol or drugs, including marijuana (caffeine and nicotine use is acceptable)
Don’t have current thoughts of suicide or a recent attempt
No bipolar, schizophrenia, schizoaffective disorder, borderline personality disorder or antisocial personality disorder diagnosis
Patients who are eligible and decide to enroll in this trial:
Will be given an intravenous infusion (into a vein for over 40 minutes) once a week of either the study drug or placebo for the treatment period (5 weeks)
Will not be charged to participate
May receive compensation for time and travel costs
May withdraw from the trial at any time, for any reason