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New treatment option for Unipolar Depression
Official title RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)
ClinicalTrials.gov ID: NCT07266545
What this study is testing
What is Vortioxetine?
Vortioxetine is an investigational medicine, given as an once-daily, being studied as a potential treatment for unipolar depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research is to understand how changes in RNA editing relate to treatment response in unipolar and bipolar depression.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Participants must meet all the following criteria to be eligible for the study:
- Adult females and males, aged 18-65 years
- Must have the capacity to understand study procedures, to comply with them for the entire length of the study, and to provide informed consent.
- Current major depressive episodes associated with MDD, BD-I, or BD-II, confirmed using the SCID-IV-CV. If a participant has already completed a...
- Symptom severity score on the Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C16) \> 10.
You likely can't join if
- All candidates meeting any of the following criteria at baseline will be excluded from study participation:
- Individuals who cannot understand English will not be enrolled because informed consent, study procedures, and interviews require comprehension of...
- Inability to provide written, voluntary informed consent due to but not limited to being under conservatorship, guardianship, commitment, or...
- Failure to score at least 75% on a 4-item comprehension assessment related to study goals, risks, and benefits
- For BD-I: not having used at least one mood stabilizer (e.g., lithium, valproate, or mood-stabilizing antipsychotics) at a stable dose and within a...
- History of treatment-refractory depression, defined as non-response to two or more antidepressant or mood-stabilizing regimens despite adequate dose...
See the full eligibility criteria
Who can join
- Participants must meet all the following criteria to be eligible for the study:
- Adult females and males, aged 18-65 years
- Must have the capacity to understand study procedures, to comply with them for the entire length of the study, and to provide informed consent.
- Current major depressive episodes associated with MDD, BD-I, or BD-II, confirmed using the SCID-IV-CV. If a participant has already completed a structured diagnostic interview within the last 2 years or participated in...
- Symptom severity score on the Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C16) \> 10.
- Ability to travel for assessment visits.
- Negative urine pregnancy test for people of childbearing potential
- People of childbearing potential must be using an acceptable method of birth control during the study, such as hormonal contraception, intrauterine device, bilateral tubal ligation, partner's documented vasectomy, or...
- BD-I patients must be on stable dose of at least one mood stabilizer (i.e., lithium, valproate, or a mood-stabilizing atypical antipsychotic at least for one month) at the time of enrollment. Patients with BD-II who...
What rules you out
- All candidates meeting any of the following criteria at baseline will be excluded from study participation:
- Individuals who cannot understand English will not be enrolled because informed consent, study procedures, and interviews require comprehension of English.
- Inability to provide written, voluntary informed consent due to but not limited to being under conservatorship, guardianship, commitment, or currently undergoing involuntary psychiatric hospitalization.
- Failure to score at least 75% on a 4-item comprehension assessment related to study goals, risks, and benefits
- For BD-I: not having used at least one mood stabilizer (e.g., lithium, valproate, or mood-stabilizing antipsychotics) at a stable dose and within a therapeutically effective antimanic range for a minimum of one month.
- History of treatment-refractory depression, defined as non-response to two or more antidepressant or mood-stabilizing regimens despite adequate dose, duration, and adherence during the current episode.
- Participants with active suicidal ideation, defined as a MADRS item #10 score greater than 4 or a "yes" response to item #4 (ideation with intent) or item #5 (ideation with plan) on the C-SSRS, will be excluded
- A medically serious suicide attempt within the past 6 months, defined as requiring emergency department evaluation, a medical procedure, or admission to a hospital (e.g., internal medicine, cardiology, or ICU)
- Current use of monoamine oxidase inhibitors or use within 14 days following discontinuation of a monoamine oxidase inhibitor
- Presence of mixed symptoms of depression, defined as a YMRS score ≥12
- Current use of any of the study medications (e.g., vortioxetine, or cariprazine) at the time of enrollment (previous use of these medications is acceptable)
- Prior hypersensitivity reaction to any of the study medications or documented non-response to any of the study medications at the maximum therapeutic dose
- A history of seizure disorder
- Recent use of long half-life psychotropic medications, including fluoxetine (in patients with BD and MDD) and long acting injectable forms of antipsychotics (mainly in BD II and MDD) within the past 4 weeks.
- Active psychosis, defined as a YMRS item #8 score \>4 or diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or schizophreniform disorder as determined by structured clinical interview
- Current drug or alcohol use disorder (excluding nicotine); full remission for at least 3 months is required for eligibility
- Positive toxicology screen for illicit substances (e.g., cocaine, methamphetamine, illegal opiates). Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be...
- Individuals who are pregnant, lactating, trying to conceive, or not using adequate contraception (e.g., hormonal contraception, intrauterine device, tubal ligation, or condoms)
- Any active or unstable medical condition judged by the principal investigator to confer excessive risk
- Clinically significant laboratory abnormality, uncontrolled hypertension (blood pressure \>160/100 mmHg), or tachycardia (heart rate \>110 bpm)
- Significant renal, hepatic, or cardiac disease; malignancy; autoimmune disease; or chronic kidney disease \> stage IIIa (estimated GFR \< 60 mL/min/1.73 m²)
- History of traumatic brain injury defined as loss of consciousness for 5 minutes and related to a trauma event
- Gastric bypass, specifically Roux-en-Y
- Clinical current diagnosis of delirium, encephalopathy, intellectual disability or cognitive disorder (mild or major neurocognitive disorder)
- Currently receiving electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) as acute or maintenance treatment
- Current use of systemic steroids, chemotherapy, and radiotherapy
- Daily use of lorazepam (Ativan) \>4 mg/day, or equivalent doses of other benzodiazepines (e.g., clonazepam \>1 mg, alprazolam \>2 mg, diazepam \>20 mg)
- No access to smartphones, internet
- Other Axis I or II diagnoses, by clinical judgments that are the current reason for treatment evaluation or play a large part of the current symptom presentation
- Ongoing treatment with opioid agonists will constitute an exclusion criterion. In contrast, other ongoing treatments, such as alcohol relapse prevention agents or ADHD pharmacotherapy, will not be considered exclusion...
- Meeting symptomatic remission criteria based on MADRS (≤ 10).
- Current use of a strong or moderate CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, fluconazole, or verapamil) strong or moderate CYP3A4 inducer (e.g., carbamazepine, rifampin, phenytoin, or St. John's Wort), due...
- Diagnosis of BD-I with concurrent use of an antipsychotic agent as a mood stabilizer.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.