Phase 4
Completed N=85
Advancing Personalized Antidepressant Treatment Using PET/MRI
Source: ClinicalTrials.gov NCT02623205 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Change From Baseline in Hamilton Depression Rating Scale at 8 Weeks — 11.81; 9.41 score on a scale
◆ Published Evidence
Established
44citations · ~11 / year
Does the change in glutamate to GABA ratio correlate with change in depression severity? A randomized, double-blind clinical trial.
Summary
Despite current medications, morbidity and mortality of Major Depressive Disorder (MDD) remain high. According to the World Health Organization, MDD affects 121 million people worldwide, and is projected to be the second leading cause of global disability by 2020. Monotherapy with selective serotonin reuptake inhibitors (SSRIs) is the most widely used treatment for MDD. However, on average, SSRIs require six weeks for onset of action, and two-thirds of those on SSRIs fail to achieve remission. Compounding this problem, patients with residual symptoms are significantly more likely to discontinue treatment or relapse, be hospitalized for medical and psychiatric conditions, or die of suicide and other causes. Although eliminating ineffective treatment trials would significantly reduce patient suffering and healthcare costs,clinicians currently do not have the tools to objectively select treatment based on an individual's likelihood of remission. Therefore, there is an urgent need to identify markers predictive of an individual's SSRI treatment outcome. Developing this personalized treatment requires increased understanding of the relationship between pretreatment neurobiology, SSRI-induced biological changes, and the corresponding symptom improvements.
Linked Publications (2)
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Does the change in glutamate to GABA ratio correlate with change in depression severity? A randomized, double-blind clinical trial.
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Lack of association between pretreatment glutamate/GABA and major depressive disorder treatment response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hamilton Depression Rating Scale at 8 Weeks |
11.81; 9.41 | — |
| SECONDARY Change From Baseline in Metabolic Rate of Glucose (MRGlu), Quantified Using Arterial Blood Analysis, at 8 Weeks |
0.507489448; 0.068629964 | — |
| SECONDARY Quantification of Brain MRGlu Without an Arterial Catheter by Training Simultaneous Estimation (SimE) |
2.0 | — |
| SECONDARY Bias of VersaPET Scanner From Measurements Taken at the Wrist and Ankle |
5 | — |
| SECONDARY Correlation Coefficient of VersaPET Scanner From Measurements Taken at the Wrist or Ankle |
0.97 | — |
Eligibility Criteria
Inclusion Criteria
- Age range: over 18 years old
- Capacity to consent
- Diagnosis of MDD and suffering from a major depressive episode
- Score of at least 22 on the MADRS
Exclusion Criteria
- Significant active physical illness, particularly those that may affect the brain
- Need for use of medication during the study that will interact with the study medication. Need to start medication that will affect study results (anti epileptics, antidepressants, beta blockers, medications with serotonergic or GABAergic modes of action)
- Patients considered at significant risk for suicide
- Patient is unlikely to be able to tolerate medication washout or the ~3 week interval (5 for fluoxetine) following washout (drug free period). Medication washouts will be supervised by a study physician.
- For females: Pregnancy, currently lactating; planning to conceive during the course of study participation, or abortion in the past two months.
- Coumadin treatment within 10 days of PET scanning
- Any MRI contraindications, including metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
- Bipolar Disorder
- Current psychosis
- High potential for excessive drug/alcohol use during the treatment period (excluding nicotine or cannabis)
- Currently taking effective antidepressant
- Currently taking an effective antidepressant
- Prior intolerance escitalopram (ESC) for ≥ 4 weeks taking ≥ ⅔ Physician's Desk Reference (PDR) maximal dose
- Significant neurological deficits
- Electroconvulsive Therapy (ECT) within the past 6 months
Data sourced from ClinicalTrials.gov (NCT02623205) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.