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New treatment option for Depression, Anxiety
Official title Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
ClinicalTrials.gov ID: NCT06004115
What this study is testing
What is Lorazepam?
Lorazepam is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for depression, anxiety.
Also referred to as Lorazepam Intensol, Ativan.
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
- This mechanistic study uses an anti anxiety drug and brain imaging to study the threat processing system and associated brain circuits in people with depression, anxiety disorders and comorbid depression and anxiety disorders. In a double blind, placebo controlled crossover design, up to 65 individuals will be recruited who will have a diagnosis of major depressive disorder (MDD) and at least one anxiety disorder (AD) (AD-MDD group), up to 65 participants will have a diagnosis of MDD and no diagnosis of an AD and up to 65 participants will have no diagnosis of MDD and a diagnosis of at least one AD will be enrolled to participate in an two session study to obtain 150 completers (50 per group).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- An individual must meet the following criteria to be considered eligible to participate in the study: All people:
- Female or male sex assigned at birth;
- Age 18-65;
- Normal or corrected to normal vision/hearing, as protocol elements may not be valid otherwise;
- Fluent English speaker, capable of providing written informed consent MDD and AD-MDD people:
You likely can't join if
- All people:
- Has uncontrolled, clinically significant neurologic (including seizure disorders): cardiovascular, pulmonary, hepatic, renal, metabolic...
- Reported body mass index (BMI) \> 40;
- History of moderate or severe traumatic brain injury, as assessed by a TBI questionnaire;
- History of eating disorder or obsessive-compulsive disorder, schizophrenia, schizo-affective disorder, bipolar disorder or any sign of psychosis;
- Current post-traumatic stress disorder (PTSD) diagnosis (although history of trauma is allowed);
See the full eligibility criteria
- An individual must meet the following criteria to be considered eligible to participate in the study: All people:
- Female or male sex assigned at birth;
- Age 18-65;
- Normal or corrected to normal vision/hearing, as protocol elements may not be valid otherwise;
- Fluent English speaker, capable of providing written informed consent MDD and AD-MDD people:
- Current major depressive episode assessed by clinician with guidance from the MINI;
- Minimum score of 55 on PROMIS Depression scale AD and AD-MDD people:
- Current anxiety disorder (generalized anxiety disorder, panic disorder, agoraphobia and social phobia) assessed by clinician with guidance from the MINI;
- Minimum score of 55 on PROMIS Anxiety Scale
- All people:
- Has uncontrolled, clinically significant neurologic (including seizure disorders): cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric...
- Reported body mass index (BMI) \> 40;
- History of moderate or severe traumatic brain injury, as assessed by a TBI questionnaire;
- History of eating disorder or obsessive-compulsive disorder, schizophrenia, schizo-affective disorder, bipolar disorder or any sign of psychosis;
- Current post-traumatic stress disorder (PTSD) diagnosis (although history of trauma is allowed);
- Current use of medications with major effects on brain function or the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake \> 1000 mg/day) following an initial list compiled by...
- Current benzodiazepine or opiate use;
- Moderate to severe current substance use disorder, defined as 5 or more symptoms of the criteria for Substance Use Disorder according to DSM 5;
- Drug or alcohol intoxication (based on positive UTOX or breathalyzer test at screening or study session) or reported alcohol/drug withdrawal, last cannabis use must be \>48 hours prior to study session;
- Has a risk of suicide according to the Investigator's clinical judgement or per Columbia-Suicide Severity Rating Scale (C-SSRS) or equivalent PhenX instrument, the subject scores "yes" on items 4 or 5 in the Suicidal...
- MRI contraindications;
- Is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during this time-period;
- Any subject judged by the Investigator to be inappropriate for the study. MDD people:
- Current (assessed by clinician with guidance from the MINI) anxiety disorder;
- Score of \> 60 on PROMIS Anxiety Scale AD people:
- Current or past recurrent major depressive episodes assessed by clinician with guidance from the MINI;
- Score of \> 60 on PROMIS Depression scale
The study team makes the final eligibility decision.
Where it's taking place
- Tulsa, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Tulsa, Oklahoma, 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.