Major Depressive DisorderPhase 4NCT06580041
Precision Care for Major Depressive Disorder
A Phase 4 study testing Pramipexole, Methylphenidate and Phenelzine in people with Major Depressive Disorder and Depression, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Depression, Depressive Disorder, Major
- What is being tested?
- Pramipexole, Methylphenidate and Phenelzine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to 1 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is able to provide informed consent
- English speaker
- 18 years of age or older at time of consent
- Meets DSM-5 criteria for Major Depressive Disorder
- The subject meets eligibility criteria for at least one study phenotype as determined by assessments, imaging and/or clinical judgment.
- PHQ-8 score at baseline of >= 10
- Scheduled for or completed intake in UCSF outpatient psychiatry
Who cannot join
- Unstable or untreated medical or psychiatric condition based on clinical assessment by investigator(s)
- Significant risk of suicidal or violent behavior as determined by clinical judgement
- In the Investigators' opinion, the subject is not capable of adhering to the protocol requirements, or the subject has a history of poor or suspected poor compliance in clinical research studies, or the subject has a history of poor or suspected poor compliance to antidepressant medication or that study participation is not in their best interest (e.g., different treatment is indicated given their clinical presentation)
- Pregnant or breastfeeding or planning to become pregnant during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nancy Friend Pritzker Psychiatry Building, University of California, San Francisco
San Francisco, California, 94107
About this study
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.
Read the detailed description
This study will classify patients seen in the Depression Clinic of the UCSF Department of Psychiatry and Behavioral Sciences into one of five phenotypes (subtypes), including: 1) Anhedonia, 2) Cognitive deficits, 3) Stress sensitivity, 4) Anxious distress, and 5) Grief.
After phenotyping, participants will be randomized to receive phenotype-specific intervention (PSI) or care as usual (CAU).
- Being tested
- Pramipexole, Methylphenidate, Phenelzine, Mindfulness-based Stress Sensitivity Therapy (MBSST), Complicated Grief Treatment (CGT)
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
CAU plan modified to include a trial of pramipexole.
MethylphenidateDrug
CAU plan modified to include a trial of methylphenidate (or, if contraindicated: guanfacine).
PhenelzineDrug
CAU plan modified to include a trial of phenelzine (or, if contraindicated: brexpiprazole).
Mindfulness-based Stress Sensitivity Therapy (MBSST)Behavioural
CAU plan modified to include a trial of MBSST. MBSST is an individual psychotherapy delivered approximately weekly for 16 sessions.
Complicated Grief Treatment (CGT)Behavioural
CAU plan modified to include a trial of CGT.
Care as usual (CAU) planOther
Unmodified CAU plan.
| Study group | Role | What they receive |
|---|---|---|
| Anhedonia phenotype: PSI | Experimental | Not described Receives: Drug: Pramipexole |
| Anhedonia phenotype: CAU | Active comparator | Not described Receives: Other: Care as usual (CAU) plan |
| Cognitive deficits: PSI | Experimental | Not described Receives: Drug: Methylphenidate |
| Cognitive deficits: CAU | Active comparator | Not described Receives: Other: Care as usual (CAU) plan |
| Stress sensitivity: PSI | Experimental | Not described Receives: Behavioral: Mindfulness-based Stress Sensitivity Therapy (MBSST) |
| Stress sensitivity: CAU | Active comparator | Not described Receives: Other: Care as usual (CAU) plan |
| Anxious distress: PSI | Experimental | Not described Receives: Drug: Phenelzine |
| Anxious distress: CAU | Active comparator | Not described Receives: Other: Care as usual (CAU) plan |
| Grief: PSI | Experimental | Not described Receives: Behavioral: Complicated Grief Treatment (CGT) |
| Grief: CAU | Active comparator | Not described Receives: Other: Care as usual (CAU) plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score
Within-phenotype and across-phenotype contrasts.
Measured: Up to 24 weeks after randomization.
Secondary outcomes (9)
Snaith-Hamilton Pleasure Scale (SHAPS) score
For anhedonia phenotype only.
Measured: Up to 24 weeks after randomization.
Clinically Useful Depression Outcome Scale Anxious Distress Specifier Subscale (CUDOS-A) score
For anxious distress phenotype only.
Measured: Up to 24 weeks after randomization.
Generalized Anxiety Disorder 7-item (GAD-7) score
For anxious distress phenotype only.
Measured: Up to 24 weeks after randomization.
Inventory of Complicated Grief (ICG) score
For grief phenotype only.
Measured: Up to 24 weeks after randomization.
Perceived Deficits Questionnaire - Depression (PDQ-D) score
For cognitive deficits phenotype only.
Measured: Up to 24 weeks after randomization.
Patient Health Questionnaire - 8 (PHQ-8) score
Within-phenotype and across-phenotype contrasts.
Measured: Up to 24 weeks after randomization.
WHO Disability Assessment Schedule (WHODAS 2.0)
Within-phenotype and across-phenotype contrasts.
Measured: Up to 24 weeks after randomization.
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) response
50% reduction from baseline score. Within-phenotype and across-phenotype contrasts.
Measured: Up to 24 weeks after randomization.
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) remission
Score < 6. Within-phenotype and across-phenotype contrasts.
Measured: Up to 24 weeks after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start12 Nov 2024
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew D. Krystal, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580041
- Sponsor's protocol ID
- 24-41815
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Care for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06580041
- Acronym / sponsor ID
- 24-41815
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will classify patients seen in the Depression Clinic of the UCSF Department of Psychiatry and Behavioral Sciences into one of five phenotypes (subtypes), including: 1) Anhedonia, 2) Cognitive deficits, 3) Stress sensitivity, 4) Anxious distress, and 5) Grief.
After phenotyping, participants will be randomized to receive phenotype-specific intervention (PSI) or care as usual (CAU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Anhedonia phenotype: PSI | Experimental | Drug: Pramipexole |
| Anhedonia phenotype: CAU | Active comparator | Other: Care as usual (CAU) plan |
| Cognitive deficits: PSI | Experimental | Drug: Methylphenidate |
| Cognitive deficits: CAU | Active comparator | Other: Care as usual (CAU) plan |
| Stress sensitivity: PSI | Experimental | Behavioral: Mindfulness-based Stress Sensitivity Therapy (MBSST) |
| Stress sensitivity: CAU | Active comparator | Other: Care as usual (CAU) plan |
| Anxious distress: PSI | Experimental | Drug: Phenelzine |
| Anxious distress: CAU | Active comparator | Other: Care as usual (CAU) plan |
| Grief: PSI | Experimental | Behavioral: Complicated Grief Treatment (CGT) |
| Grief: CAU | Active comparator | Other: Care as usual (CAU) plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is able to provide informed consent
- English speaker
- 18 years of age or older at time of consent
- Meets DSM-5 criteria for Major Depressive Disorder
- The subject meets eligibility criteria for at least one study phenotype as determined by assessments, imaging and/or clinical judgment.
Key exclusion criteria (4 listed)
- Unstable or untreated medical or psychiatric condition based on clinical assessment by investigator(s)
- Significant risk of suicidal or violent behavior as determined by clinical judgement
- In the Investigators' opinion, the subject is not capable of adhering to the protocol requirements, or the subject has a history of poor or suspected poor compliance in clinical research studies, or the subject has a history of poor or suspected poor compliance to antidepressant medication or that study participation is not in their best interest (e.g., different treatment is indicated given their clinical presentation)
- Pregnant or breastfeeding or planning to become pregnant during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PramipexoleCAU plan modified to include a trial of pramipexole. | Drug | Anhedonia phenotype: PSI |
| MethylphenidateCAU plan modified to include a trial of methylphenidate (or, if contraindicated: guanfacine). | Drug | Cognitive deficits: PSI |
| PhenelzineCAU plan modified to include a trial of phenelzine (or, if contraindicated: brexpiprazole). | Drug | Anxious distress: PSI |
| Mindfulness-based Stress Sensitivity Therapy (MBSST)CAU plan modified to include a trial of MBSST. MBSST is an individual psychotherapy delivered approximately weekly for 16 sessions. | Behavioural | Stress sensitivity: PSI |
| Complicated Grief Treatment (CGT)CAU plan modified to include a trial of CGT. | Behavioural | Grief: PSI |
| Care as usual (CAU) planUnmodified CAU plan. | Other | Anhedonia phenotype: CAU, Anxious distress: CAU, Cognitive deficits: CAU, Grief: CAU, Stress sensitivity: CAU |
Primary outcome
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score
Time frame: Up to 24 weeks after randomization.
Within-phenotype and across-phenotype contrasts.
9 secondary outcomes
Snaith-Hamilton Pleasure Scale (SHAPS) score
Time frame: Up to 24 weeks after randomization.
Clinically Useful Depression Outcome Scale Anxious Distress Specifier Subscale (CUDOS-A) score
Time frame: Up to 24 weeks after randomization.
Generalized Anxiety Disorder 7-item (GAD-7) score
Time frame: Up to 24 weeks after randomization.
Inventory of Complicated Grief (ICG) score
Time frame: Up to 24 weeks after randomization.
Perceived Deficits Questionnaire - Depression (PDQ-D) score
Time frame: Up to 24 weeks after randomization.
Patient Health Questionnaire - 8 (PHQ-8) score
Time frame: Up to 24 weeks after randomization.
WHO Disability Assessment Schedule (WHODAS 2.0)
Time frame: Up to 24 weeks after randomization.
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) response
Time frame: Up to 24 weeks after randomization.
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) remission
Time frame: Up to 24 weeks after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew D. Krystal, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pramipexole, Methylphenidate and Phenelzine in people with Major Depressive Disorder and Depression, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depressive Symptoms - Self-Report 16-Item (QIDS-SR-16) score (time frame: Up to 24 weeks after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.