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Behavioral Intervention

Stress sensitivity: PSI for Depression

Phase 4
Waitlist Available
Led By Andrew D. Krystal, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Participant is able to provide informed consent
* English speaker
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks after randomization.
Awards & highlights

Summary

This study aims to assess whether phenotyping-guided intervention selection is superior to intervention selection without phenotyping guidance (i.e., routine clinician and patient judgment regarding treatment selection) for depression.

Who is the study for?
This trial is for individuals with major depressive disorder who are seeking new treatment options. Participants should be diagnosed with depression and willing to try different therapies such as mindfulness, medication, or standard care.
What is being tested?
The study tests if choosing treatments based on individual characteristics (phenotyping) is better than usual selection methods for depression. Therapies include Mindfulness-based Stress Sensitivity Therapy, medications like Pramipexole and Phenelzine, and standard care.
What are the potential side effects?
Possible side effects may include nausea, dizziness from Pramipexole; insomnia or increased blood pressure from Methylphenidate; headaches or sleepiness from Phenelzine; and general discomfort from therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks after randomization.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks after randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score
Secondary study objectives
Clinically Useful Depression Outcome Scale Anxious Distress Specifier Subscale (CUDOS-A) score
Generalized Anxiety Disorder 7-item (GAD-7) score
Inventory of Complicated Grief (ICG) score
+6 more

Trial Design

10Treatment groups
Experimental Treatment
Active Control
Group I: Stress sensitivity: PSIExperimental Treatment1 Intervention
Group II: Grief: PSIExperimental Treatment1 Intervention
Group III: Cognitive deficits: PSIExperimental Treatment1 Intervention
Group IV: Anxious distress: PSIExperimental Treatment1 Intervention
Group V: Anhedonia phenotype: PSIExperimental Treatment1 Intervention
Group VI: Cognitive deficits: CAUActive Control1 Intervention
Group VII: Anhedonia phenotype: CAUActive Control1 Intervention
Group VIII: Stress sensitivity: CAUActive Control1 Intervention
Group IX: Anxious distress: CAUActive Control1 Intervention
Group X: Grief: CAUActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pramipexole
2008
Completed Phase 4
~11170
Methylphenidate
2014
Completed Phase 4
~431850
Phenelzine
2021
Completed Phase 1
~220

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,531 Previous Clinical Trials
15,243,232 Total Patients Enrolled
72 Trials studying Depression
26,333 Patients Enrolled for Depression
Andrew D. Krystal, MDPrincipal InvestigatorUniversity of California, San Francisco
~100 spots leftby Sep 2029
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