Still Feeling Stuck? Consider a Clinical Study for Depression
Research Study on Investigational Medication for Treatment-Resistant Depression
Steve Strakowski
Primary Investigator
Brief description of study
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Detailed description of study
We are looking for adults between the ages of 18 and 75, currently taking 1 to 2 antidepressants, to take part in a clinical study. The PACE-1 Study is helping researchers learn more about an investigational treatment for Treatment-Resistant Depression (TRD).
TRD is a form of depression that does not improve, or only improves a little bit, after trying at least 2 different antidepressant medications, as prescribed by your doctor.
Qualified participants may receive payment for their study-related time and travel.
If you are interested in participating, please visit https://redcap.link/alto-207-201-7169 or contact the study site at mood@iu.edu or (463) 201-3006.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Treatment-resistant Depression (TRD)
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Age: 18 years - 75 years
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Gender: All
Inclusion Criteria:
- Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
- Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
- Failure to respond (<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
- Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline
Exclusion Criteria:
- Evidence of unstable medical condition
- Concurrent use of any prohibited medications or substance use disorder
- Diagnosed bipolar disorder or a psychotic disorder or symptoms
- Significant current PTSD symptoms or history of PTSD
- Clinically significant current impulse control difficulties
- Has a history of hypersensitivity or allergic reaction to ALTO-207 or any of its components/excipients
- Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
This study investigates the effects of an investigational medication on adults with treatment-resistant depression (TRD). TRD is when a person with major depressive disorder (MDD) does not respond to at least two different antidepressant treatments. The purpose of this study is to compare depressive symptoms in participants receiving the investigational medication with those receiving a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
Participants will be randomly assigned to one of two study arms: one receiving the investigational medication and the other receiving a placebo. The study will be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment. Participants will continue their current antidepressant treatment while also receiving the study medication or placebo.
- Who can participate: Adults aged 18 to 75 years with major depressive disorder (MDD) unresponsive to at least two antidepressant treatments are eligible. Participants must be on a stable dose of 1 to 2 oral antidepressants and free from unstable medical conditions or other psychiatric disorders.
- Study details: Participants will take part in a double-blind research study, receiving either an investigational medication or a placebo while continuing their current antidepressant treatment.
- Study timelines: The study will last up to approximately 17 weeks.
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