Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Laureate Institute for Brain Research, Inc.
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses Lorazepam, an anti-anxiety medication, to study how people with depression, anxiety, or both react to threats. The study aims to see if these groups process threats differently and how they respond to the medication. Lorazepam helps calm the brain, and the scans show which areas are involved in threat processing. Lorazepam has been used in various studies to treat anxiety and has shown effectiveness in improving emotional states in patients with anxiety.
What safety data exists for lorazepam in treating depression and anxiety?Lorazepam is a benzodiazepine used to manage anxiety and has been studied for its safety and efficacy. Common side effects include sedation, dizziness, weakness, unsteadiness, and disorientation, which can impair activities like driving. A clinical study showed lorazepam was superior to placebo in treating anxiety without significant changes in vital signs or lab values, and only one side effect, urinary retention, was reported. Lorazepam is also used for various off-label indications, but shortages have led to the use of alternatives like midazolam.15789
Is the drug Lorazepam a promising treatment for depression and anxiety?Yes, Lorazepam is a promising treatment for anxiety and depression. Studies show it is more effective than a placebo in reducing anxiety, even in patients with depression. It also works well for anxiety related to other conditions, like chronic enteritis and ulcerative colitis. In some cases, it helps improve anxiety symptoms faster than other drugs.12349
Do I need to stop taking my current medications to join the trial?The trial does not require you to stop taking your current medications if you are on antidepressants like SSRIs, TCAs, SNRIs, or Bupropion, as long as you haven't changed the dose or medication in the past 6 weeks. However, you cannot participate if you are currently using benzodiazepines, opiates, or medications that significantly affect brain function or fMRI results.
What data supports the idea that Lorazepam for Depression and Anxiety is an effective drug?The available research shows that lorazepam is effective in reducing anxiety symptoms in patients who also have depression. In one study, lorazepam was found to provide better anxiety relief than a placebo, with significant improvements noted. Another study confirmed that lorazepam was superior to a placebo in treating anxiety, with patients showing greater improvement in symptoms. These studies suggest that lorazepam can be an effective option for managing anxiety and depression.12689
Eligibility Criteria
This trial is for individuals with major depressive disorder (MDD) and/or an anxiety disorder. Participants must be fluent in English, have normal vision/hearing, and not be pregnant or planning pregnancy soon. They should not have a history of certain mental health disorders like schizophrenia or bipolar disorder, no recent medication changes, and no MRI contraindications.Participant Groups
The study tests the effects of Lorazepam versus a placebo on threat sensitivity in people with depression alone, anxiety alone, or both. It involves brain imaging to observe how different groups respond to threats after taking the drug or placebo in two sessions totaling about 10.5 hours.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LorazepamExperimental Treatment1 Intervention
Participants will receive a single 1mg dose of Lorazepam, to be taken orally under registered nurse (RN) supervision
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo, to be taken orally under RN supervision
Lorazepam is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Ativan for:
- Anxiety disorders
- Short-term relief of anxiety symptoms
- Preoperative sedation
🇪🇺 Approved in European Union as Ativan for:
- Anxiety disorders
- Insomnia
- Preoperative sedation
🇨🇦 Approved in Canada as Ativan for:
- Anxiety disorders
- Short-term relief of anxiety symptoms
- Preoperative sedation
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Laureate Institute for Brain ResearchTulsa, OK
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Who is running the clinical trial?
Laureate Institute for Brain Research, Inc.Lead Sponsor
National Institute of Mental Health (NIMH)Collaborator
California Institute of TechnologyCollaborator
References
Clinical assessment of the safety and efficacy of lorazepam, a new benzodiazepine derivative, in the treatment of anxiety. [2013]In a four-week double-blind study of 68 adult outpatients, lorazepam a new benzodiazepine, administered at an average total daily dosage level of 3.1 mg on a b.i.d. regimen, was clearly superior to placebo in the treatment of neurotic anxiety and its related symptoms. The lorazepam-treated group showed significantly greater improvement than the placebo-treated group (both clinically and statistically), as evidenced by the greater changes on the physician-rated Global Scale as well as by the greater changes in almost all categories on the physician-rated Hamilton Anxiety Scale and the patient-rated Lipman-Rickels 35-Item Self-Rating Scale. There were no clinically significant changes in vital signs or laboratory values and only one side effect, urinary retention (resolved without discontinuing the drug), was reported.
Studies with oral lorazepam in anxiety neurosis associated with depressive symptomatology. [2013]Twelve studies were undertaken under a common four-week protocol to investigate the efficacy of lorazepam compared with placebo in reducing the severity of moderate to severe anxiety in 264 patients also having significant depressive symptomatology. Analysis of the results indicated that lorazepam gave generally better anxiety relief than placebo; in the majority of comparisons the differences were substantial enough to be both statistically and clinically significant. No data were obtained evidencing significant toxicity in either treatment group.
Lorazepam in anxiety associated with chronic enteritis and ulcerative colitis. [2013]Using a common protocol, 9 gastroenterologists assessed the comparative antianxiety efficacy of lorazepam and placebo under double-blind conditions in 48 patients with moderate to severe anxiety associated with chronic enteritis and ulcerative colitis. The initial dose of lorazepam was 3 mg per day given b.i.d., 2 mg h.s. and 1 mg a.m.; the duration of treatment was 4 weeks. The physician-rated Global and Hamilton and patient-rated 35-Item Scales were used. Efficacy was analyzed from the results of the pooled patient data. By all 3 rating scales and at virtually all times of assessment, lorazepam was associated with statistically significantly greater improvement in symptoms related to anxiety associated with chronic enteritis and ulcerative colitis than was placebo. Side effects in general were infrequent. (J Clin Psychiatry 39:[No. 10--2] 53--57, 1978).
A multicentre double-blind comparative trial of fluvoxamine versus lorazepam in mixed anxiety and depression treated in general practice. [2019]Fluvoxamine, a selective serotonin reuptake inhibitor, was compared with lorazepam in a multicentre double-blind, parallel group study in 112 general practice patients with mixed anxiety and depression. For inclusion, patients were required to have minimum baseline scores of 21 on the Montgomery-Asberg Depression Rating Scale (MADRS) and 11 on the Clinical Anxiety Scale (CAS). Treatment was for 6 weeks. There were no significant differences between treatments at any point except in an elderly subgroup in whom anxiety improved more rapidly with lorazepam. There were significant improvements in MADRS, CAS and global ratings compared with baseline at all subsequent assessments. Improvement continued during the whole treatment period. Lorazepam produced more sedation, whilst fluvoxamine produced significantly more nausea and vomiting; this was usually early in onset and, if tolerated, resolved during the course of the study. As it is now widely recognized that benzodiazepines should only be given in short courses of 2-4 weeks, the continued improvement up to 6 weeks has implications regarding choice of treatment.
A comparison of the safety and efficacy of alprazolam versus other agents in the treatment of anxiety, panic, and depression: a review of the literature. [2022]A review of the worldwide published literature was conducted to assess the efficacy and safety of alprazolam for the treatment of anxiety disorders, panic disorder, and depression in comparison with those of other active drugs (including other benzodiazepines and antidepressant medications). In all, a total of 8878 patients participated in the 84 active-drug-controlled studies that were reviewed: 3574 were treated with alprazolam, 3666 were treated with another active drug, and 1638 were treated with placebo. Two general findings emerged: (1) Alprazolam demonstrates efficacy for the treatment of anxiety disorders, panic disorder, and depression in the large majority of studies; for these illnesses, it appeared equal in efficacy to the active agents with which it was compared. (2) Medical events, such as depression, suicidality, hostility/aggression, mania/psychosis, abuse, withdrawal reactions, and seizures, were reported infrequently or not at all for alprazolam and the comparator drugs; there were no marked differences between drug classes in the frequencies of these events.
A double-blind study of lorazepam versus the combination of haloperidol and lorazepam in managing agitation. [2013]To compare the utility of intramuscular lorazepam (LZ) with the combination of intramuscular haloperidol (HDL) and LZ to control acutely agitated behavior.
Lorazepam and driving impairment. [2019]Lorazepam (Ativan), is a benzodiazepine frequently used to manage anxiety, presurgically, and as a sedative. Common side effects include sedation, dizziness, weakness, unsteadiness, and disorientation. Consequently, lorazepam can have a significant effect on driving ability. We reviewed all positive lorazepam drug-impaired driving cases submitted to the Washington State Toxicology Laboratory between January 1998 and December 2003. The mean concentration found in the blood of these drivers (n = 170) was 0.048 mg/L (std. dev. = 0.06, median = 0.03). Concentrations ranged from
[Use of injectable lorazepam in status epilepticus: a comparative study in French-speaking hospitals]. [2015]Injectable lorazepam (IL) is marketed in many countries but in France is only available within the framework of a compassionate use program for refractory status epilepticus. This study aims to evaluate the differences of pediatric use and status of IL in the hospitals of the Mother-Child French-speaking Network (Réseau mère-enfant de la francophonie, i.e., RMEF).
Surge of Midazolam Use in the Midst of Lorazepam Shortage. [2023]Lorazepam is a widely prescribed benzodiazepine that is used to manage anxiety, insomnia, and status epilepticus and is used for pre-anesthetic care as well as several off-label indications including aggression, alcohol withdrawal, panic disorder, chemotherapy-associated anticipatory nausea, and catatonia. Recent increases in demand, manufacturing changes, and quality control issues have resulted in a shortage of injectable and oral lorazepam, prompting clinicians to use alternatives. One such alternative is midazolam, a drug that has been used primarily in the intensive care unit and anesthesia settings.