Phase 3
Completed N=54
Study of Neural Responses Induced by Antidepressant Effects
Source: ClinicalTrials.gov NCT02674529 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores — 11; 12 score on a scale — p=0.58
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The proposed work aims to examine the neural changes associated with fast-acting antidepressant treatments in order to develop imaging-based biomarkers of treatment response for depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores |
11; 12 | 0.58 |
| SECONDARY Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores |
6.82; 5.54 | 0.8 |
| SECONDARY Neural Responses During the Sham Neurofeedback fMRI Task. |
1.1 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- A man or woman age of 18 or older.
- Currently experiencing a depressive episode as part of Major Depressive Disorder.
- Able to tolerate lying still on your back for 60 minutes at a time.
- Have had no more than one failed antidepressant trial of adequate dose and duration.
- Have been antidepressant medication-free for at least 21 days prior to collection of imaging data (5 weeks for fluoxetine)
Exclusion Criteria
- Are currently taking any psychiatric medication, or any potentially augmenting or sedative drugs.
- Have a history of inadequate response/tolerability to escitalopram; or history of resistant depression
- Pregnant or breastfeeding or plan to become pregnant over the duration of the study.
- Have a history (lifetime) of psychotic depressive, schizophrenic, bipolar, schizoaffective, or other Axis I psychotic disorders.
- Meet criteria for substance dependence in the last 6 months, except nicotine, or substance abuse in the last 2 months.
- Have a medical condition that contradicts treatment with escitalopram.
- Are currently receiving psychotherapy or any other treatment for your depression.
Data sourced from ClinicalTrials.gov (NCT02674529). 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.