Limbitrol

Depression, Enterocolitis, Anxiety Disorders + 6 more

Treatment

8 FDA approvals

20 Active Studies for Limbitrol

What is Limbitrol

Chlordiazepoxide

The Generic name of this drug

Treatment Summary

Amitriptyline hydrochloride, also known as Elavil, is a type of antidepressant medication used to treat depression and nerve-related pain. It was first released in 1977 and is manufactured by Sandoz.

Librax

is the brand name

image of different drug pills on a surface

Limbitrol Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Librax

Chlordiazepoxide

1966

112

Approved as Treatment by the FDA

Chlordiazepoxide, otherwise known as Librax, is approved by the FDA for 8 uses like Enterocolitis and Irritable Bowel Syndrome .

Enterocolitis

Used to treat acute Enterocolitis in combination with Clidinium

Irritable Bowel Syndrome

Used to treat Irritable Bowel Syndrome (IBS) in combination with Clidinium

Irritable Bowel Syndrome (IBS)

Used to treat Irritable Bowel Syndrome (IBS) in combination with Clidinium

acute Enterocolitis

Used to treat acute Enterocolitis in combination with Clidinium

Depression

Used to treat Depression in combination with Amitriptyline

Peptic Ulcer Disease

Used to treat Peptic Ulcer Disease in combination with Clidinium

Anxiety

Used to treat moderate to severe anxiety in combination with Amitriptyline

moderate to severe symptoms

Used to treat moderate to severe symptoms in combination with Amitriptyline

Effectiveness

How Limbitrol Affects Patients

Amitriptyline is a painkiller and anti-depressant. Clinical trials have found it to be effective in treating post-herpetic neuralgia, diabetic neuropathic pain, neurogenic pain, and chronic non-malignant pain. It may also help with fibromyalgia. Amitriptyline has strong anticholinergic properties that can affect the heart, potentially leading to arrhythmia. Elderly patients may experience orthostatic hypotension and tachycardia when taking normal doses for depression. It can also cause changes in blood sugar levels. Lastly, it can lower the convulsive

How Limbitrol works in the body

We don't know exactly how amitriptyline works, but it is thought to increase the levels of serotonin and norepinephrine in the brain. These neurotransmitters are important for regulating mood, and a lack of them can lead to depression. This drug increases their levels, which may explain why it helps improve depressive symptoms. It's unclear if this drug's pain-relieving effects are related to its mood-altering activities or something else.

When to interrupt dosage

The prescribed measure of Limbitrol is contingent upon the diagnosed circumstance, including moderate Agitation, intense agitation and Anxiety. Dosage may also differ as per the strategy of delivery (e.g. Tablet, film coated - Oral or Syrup) detailed in the table below.

Condition

Dosage

Administration

moderate to severe symptoms

, 5.0 mg, 10.0 mg, 25.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Depression

, 5.0 mg, 10.0 mg, 25.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Enterocolitis

, 5.0 mg, 10.0 mg, 25.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Anxiety Disorders

, 5.0 mg, 10.0 mg, 25.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Irritable Bowel Syndrome

, 5.0 mg, 10.0 mg, 25.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Peptic Ulcer Disease

, 5.0 mg, 10.0 mg, 25.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Syndrome

, 5.0 mg, 10.0 mg, 25.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Anxiety

, 5.0 mg, 10.0 mg, 25.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Anxiety

, 5.0 mg, 10.0 mg, 25.0 mg

, Oral, Capsule, Capsule - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Warnings

Limbitrol has four contraindications; thus, it should not be ingested when encountering any of the conditions in the following table.

There are 20 known major drug interactions with Limbitrol.

Common Limbitrol Drug Interactions

Drug Name

Risk Level

Description

Azelastine

Major

Chlordiazepoxide may increase the central nervous system depressant (CNS depressant) activities of Azelastine.

Deutetrabenazine

Major

The risk or severity of sedation and somnolence can be increased when Chlordiazepoxide is combined with Deutetrabenazine.

Ethanol

Major

Chlordiazepoxide may increase the central nervous system depressant (CNS depressant) activities of Ethanol.

Methadone

Major

Chlordiazepoxide may increase the central nervous system depressant (CNS depressant) activities of Methadone.

Oliceridine

Major

The risk or severity of hypotension, sedation, death, somnolence, and respiratory depression can be increased when Chlordiazepoxide is combined with Oliceridine.

Limbitrol Toxicity & Overdose Risk

Amitriptyline can be toxic if taken in large doses. If someone takes 750mg or more, they may experience symptoms like low blood pressure, confusion, seizures, dilated pupils, difficulty concentrating, drowsiness, hallucinations, irregular heartbeat, and possibly coma. Taking amitriptyline while pregnant or breastfeeding is not recommended due to the risk to the baby. Animal studies have shown that amitriptyline can affect fertility and may have genotoxic potential. Long-term studies on its carcinogenic effects have not been done yet.

image of a doctor in a lab doing drug, clinical research

Limbitrol Novel Uses: Which Conditions Have a Clinical Trial Featuring Limbitrol?

1230 active trials are currently underway to assess the potential of Limbitrol to alleviate symptoms of Depression, Bulimia Nervosa and Migraine.

Condition

Clinical Trials

Trial Phases

Anxiety Disorders

51 Actively Recruiting

Phase 2, Not Applicable, Phase 4, Phase 3, Early Phase 1

Enterocolitis

0 Actively Recruiting

Irritable Bowel Syndrome

5 Actively Recruiting

Not Applicable, Phase 2, Early Phase 1

Syndrome

4 Actively Recruiting

Phase 2, Phase 3, Not Applicable

Peptic Ulcer Disease

0 Actively Recruiting

Anxiety

2 Actively Recruiting

Not Applicable

Anxiety

0 Actively Recruiting

Depression

290 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Early Phase 1, Phase 4, Phase 3

moderate to severe symptoms

0 Actively Recruiting

Limbitrol Reviews: What are patients saying about Limbitrol?

5

Patient Review

10/26/2009

Limbitrol for Anxiousness associated with Depression

I had a good experience with this medication, taking both the 12.5 mg and 5mg doses. I have Generalized Anxiety Disorder, some depression, and an overactive bladder--all of which significantly improved while I was on Limbitrol. A few months ago, I stopped taking the medication to see how things would go without it; now I'm planning to ask my doctor if we can just try Amitriptlyne to see what happens.

5

Patient Review

9/13/2010

Limbitrol for Anxiousness associated with Depression

I've used this treatment for over two decades with great success. It's prevented any recurrence of my depression and has helped me sleep better and manage anxiety. I only need to take a small dose at bedtime, and any side effects like sleepiness or dizziness have gone away after continued use. The only downside is that it can cause weight gain.

5

Patient Review

3/10/2008

Limbitrol for Anxiousness associated with Depression

I've been taking this medication for over ten years to treat my migraines. Recently, it's become impossible to find at any local or mail-order pharmacy. The generic, amitriptyline, doesn't work for me. I take amitriptyline with librium, and it's not as effective as limbitrol.

5

Patient Review

9/5/2009

Limbitrol for Anxiousness associated with Depression

I've been taking this medication for migraines for a week now. I still get headaches, but they're not migraines anymore (I've only had 3 since starting the drug). I do feel somewhat depressed at times, and find myself eating more than usual!

5

Patient Review

12/24/2008

Limbitrol for Anxiousness associated with Depression

Limbitrol has really helped me by reducing my depression and helping me sleep. I no longer cry every day, and I'm feeling much better overall.

5

Patient Review

12/3/2012

Limbitrol for Anxiousness associated with Depression

I've been taking this medication for 15 years and it's always worked well for me. Recently, I tried to stop taking it and experienced terrible itching as a result. Once I started taking the medicine again, the itching stopped.

5

Patient Review

8/2/2012

Limbitrol for Anxiousness associated with Depression

I took this for over 25 years and found it very effective; however, when I tried to switch from this to another drug, I had severe withdrawals as I did not wean myself slowly enough. Mom has taken it for 20+ years and now that she's terminal, the doctor switched her to ativan, supposedly to keep her comfortable. Disastrous! I switched her back to Limbitrol and she is much calmer. Beware of withdrawal!

5

Patient Review

10/17/2015

Limbitrol for Anxiousness associated with Depression

I've been taking this medication for a decade now and it's really helped me. My neurologist said he'd put it in the drinking water if he could! I haven't experienced any negative side effects, which is great.

5

Patient Review

5/16/2017

Limbitrol for Anxiousness associated with Depression

I've been taking this medication on and off for over 25 years, and it's still effective. I don't understand why they would discontinue it; it's a great drug that provides a calming feeling during panic attacks.

5

Patient Review

12/21/2020

Limbitrol for Anxiousness associated with Depression

I'm a computer software analyst, so I always have to be on my toes at work. This medication helps me stay focused and clear-headed while performing my job duties.

4.7

Patient Review

10/24/2009

Limbitrol for Anxiousness associated with Depression

This medication helped to ease my nerves during extreme anxiety attacks.

4.3

Patient Review

4/28/2011

Limbitrol for Anxiousness associated with Depression

I found that I would wake up in the middle of the night after taking this medication, which was around 3 or 4am.

4

Patient Review

7/9/2010

Limbitrol for Anxiousness associated with Depression

Limbitrol has been great for me in reducing the frequency of my migraines. I was having a couple per week, but since starting this medication, I've only had one in the last month. The dry mouth and morning grogginess are manageable side effects.

4

Patient Review

11/21/2011

Limbitrol for Anxiousness associated with Depression

I'm really hoping that Limbitrol hasn't been discontinued. I've been using it for six years and it's been incredibly effective for me. If you have any information on this, please let me know.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about limbitrol

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Limbitrol been discontinued?

"The Limbitrol brand is no longer available in the United States. If there are generic versions of this product that have been approved by the FDA, there may be generic equivalents available."

Answered by AI

What are the side effects of Limbitrol?

"If you experience any of the following rare but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: fainting, muscle weakness, unusual tiredness.

Possible side effects from taking this medication include feeling drowsy or dizzy, a dry mouth, blurred vision, constipation, bloating, difficulty urinating, and weight gain. If any of these effects become bothersome, inform your doctor or pharmacist. To reduce the risk of feeling dizzy or faint, stand up slowly when getting up from a sitting or lying position. Seek medical help immediately if you experience any of the following rare but serious side effects while taking this medication: fainting, muscle weakness, or unusual fatigue."

Answered by AI

What is Limbitrol prescribed for?

"LIMBITROL may be useful for treating patients with moderate to severe depression who also have moderate to severe anxiety. LIMBITROL may be more effective and have fewer treatment failures than using amitriptyline or chlordiazepoxide alone."

Answered by AI

Clinical Trials for Limbitrol

Image of Stanford University School of Medicine in Stanford, United States.

BEAR Program for Suicidal Thoughts

18 - 75
Female
Stanford, CA

The current study aims to test the feasibility of a new form of group therapy for women who have a history of interpersonal trauma and current suicidal ideation. The Building Empowerment and Resilience (BEAR) Therapeutic group has been adapted for women who have experienced trauma and have current suicidal ideation. It incorporates psychological skills, psychoeducation about trauma and gender-based violence, and physical self-defense training, all within a therapeutic process. It will be implemented with women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect) and experience various mental health difficulties, including suicidal ideation. We aim to assess the feasibility to recruit and implement the BEAR group. Our ultimate aim is to assess whether the program can effect self-efficacy and suicidal ideation.

Waitlist Available
Has No Placebo

Stanford University School of Medicine

Jennifer Keller, PhD

Image of Western Psychiatric Hospital/University of Pittsburgh in Pittsburgh, United States.

Sleep and Circadian Interventions for Suicide

18 - 25
All Sexes
Pittsburgh, PA

The purpose of this study is to examine the extent to which delivering sleep and circadian focused interventions in addition to evidenced based psychiatric care for depression and suicide risk may contribute to decreasing suicide risk among high risk young adults. Investigators will evaluate three interventions targeting sleep in acutely suicidal college students enrolled in intensive outpatient treatment. Participants will be randomly assigned to one of three intervention groups: 1. Triple Chronotherapy (TCT)+ Transdiagnostic Sleep and Circadian Intervention (TSC) 2. Transdiagnostic Sleep and Circadian Intervention (TSC) 3. Sleep Feedback (SF) Participants will be followed for 6 months with primary outcome domains of suicidal thoughts and behaviors and depression evaluated by blinded clinicians at short (Days 1-4 of intervention), medium (2 months) and long (6 month) term intervals.

Waitlist Available
Has No Placebo

Western Psychiatric Hospital/University of Pittsburgh

Tina Goldstein, PhD

Image of University of South Florida in Tampa, United States.

WeACT Program for Caregivers of People With Dementia

18+
All Sexes
Tampa, FL

The goal of this clinical trial is to learn whether WeACT, a self-paced, web-based program, is feasible and helpful for adult family caregivers of a relative living with dementia. WeACT is based on acceptance and commitment therapy (ACT), which teaches skills to handle difficult thoughts and feelings and take steps toward what matters most. The main questions this study aims to answer are: * Can caregivers complete WeACT as planned? * Do caregivers show improvements in mental health and coping after using WeACT? * What are caregivers' experiences with the program, and what suggestions do they have to improve it? Participants will: * Complete six self-paced weekly online modules and use the daily practice section during the program. * Complete online questionnaires before starting and after completing the program. * Take part in one online interview about their experience.

Waitlist Available
Has No Placebo

University of South Florida

Areum Han

Have you considered Limbitrol clinical trials?

We made a collection of clinical trials featuring Limbitrol, we think they might fit your search criteria.
Go to Trials
Image of Fred Hutch/University of Washington Cancer Consortium in Seattle, United States.

Psilocybin Therapy for Anxiety and Depression in Cancer

18 - 85
All Sexes
Seattle, WA

This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incurable). For patients with metastatic, incurable cancer, unrelieved anxiety and existential distress can cause profound suffering. Psilocybin therapy can relieve anxiety and existential distress by disrupting patterns of thinking that contribute to anxiety and depression. Psilocybin is a substance being studied in the treatment of anxiety or depression in patients with cancer. In this study, a pharmaceutical grade of psilocybin will be used that has been approved by the FDA for research, provided by Filament Health. Psilocybin acts on the brain by resetting the brain's activity and increasing connections between brain regions, particularly those involved in mood regulation and self-perception. In this study psilocybin is combined with structured discussions and reflections that enable patients to have new insights about their situation. In a prior study, group retreat psilocybin therapy was proven to be safe and this study tests a refined dosing regimen for symptoms of anxiety and depression in patients with metastatic solid tumors or incurable hematologic malignancies.

Phase 2
Waitlist Available

Fred Hutch/University of Washington Cancer Consortium

Anthony Back, MD

Image of Wahwala Iyohlogya/Peaceful Means in Pine Ridge, United States.

Lakota Family Acceptance Program for Depression and Anxiety

Any Age
All Sexes
Pine Ridge, SD

The goal of this open pilot trial (OPT) is to develop a Lakota-adapted Family Acceptance Project (LFAP) for Indigenous 2SLGBTQ+ youth and their caregivers. The OPT is specifically focused on acceptability, feasibility, and safety of programming and research protocols. The investigators will also examine pre- to post- changes on outcomes for the sole purposes of making sure scores on measures are changing in the hypothesized direction (e.g., depression scores are going from moderate to minimal as opposed to no change or depression scores increasing). Once enrolled in the study, participants complete a baseline survey. Then participants will engage in LFAP which is an 8-session group intervention; sessions will be scheduled once a week for eight weeks (at 2 hours per session). Participants will complete survey instruments before and immediately after the program sessions, in addition to post-program surveys and an exit interview.

Recruiting
Has No Placebo

Wahwala Iyohlogya/Peaceful Means (+1 Sites)

Katie Edwards, PhD

Image of Seaway Valley Community Health Centre (Cardiac Rehab Program) in Cornwall, Canada.

FRAME for Heart Failure

18+
All Sexes
Cornwall, Canada

Heart failure is a high-risk, chronic condition that impacts patients' mental health. Approximately 50% of heart failure patients experience comorbid mental health conditions, such as stress, depression and anxiety, which affect their day-to-day lives. Despite this interconnection, the integration of mental health awareness and support into cardiac care remains limited. To address this gap, the FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, healthcare providers, health system decisionmakers, and patient partners. This pilot study evaluates the feasibility of implementing the FRAME intervention in pilot clinical sites within two health regions in Ontario, Canada, including team-based family medicine clinics, cardiac rehabilitation/specialist clinics, and emergency departments. Utilizing a pretest-posttest hybrid 1 model intervention design, this study evaluates process indicators and patient-focused outcomes through surveys and semi-structured qualitative interviews. Findings from this study will inform a future large scale cohort study and scalable integration of the FRAME tool into existing cardiac care pathways to enhance mental health awareness and support among heart failure patients.

Recruiting
Has No Placebo

Seaway Valley Community Health Centre (Cardiac Rehab Program) (+8 Sites)

Have you considered Limbitrol clinical trials?

We made a collection of clinical trials featuring Limbitrol, we think they might fit your search criteria.
Go to Trials
Image of Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton in Hamilton, Canada.

Mindfulness for Postpartum Anxiety

18+
Female
Hamilton, Canada

Postpartum anxiety (PPA) affects up to 20% of mothers in the first year after delivery, with mothers often reporting both psychological and physical symptoms. Present non-pharmacological interventions are effective at improving some psychological aspects of PPA such as anxiety, depressive mood, and distress. However, current interventions are not effective in improving emotion regulation (ER), something that many with PPA experience impairment in. Current interventions also seldom target the physical aspects of anxiety, such as bodily awareness - sensing and understanding internal signals in the body (e.g., sensing a fast heartbeat). There is a link between ER and bodily awareness, however psychological interventions that target both these aspects have not been investigated in the PPA population. As a result, a mind-body intervention targeting both ER and bodily awareness is needed to offer a more holistic treatment option. The purpose of the proposed study is to test the effectiveness of a 4-week mindfulness intervention on anxiety symptoms, ER, and bodily awareness in those with PPA. We will use self-report questionnaires alongside brain imaging (functional magnetic resonance imaging; fMRI) to evaluate the effectiveness. Combining both subjective and objective measures will provide greater confidence in our findings, ensuring a more comprehensive understanding of the intervention's impact. Self-report questionnaires will be administered at enrolment, immediately post-intervention, and 4 weeks post-intervention. Brain imaging will be conducted at enrolment and immediately post-intervention. We believe this intervention will lead to improvements in anxiety symptoms, ER, and bodily awareness on the questionnaires and fMRI scans. If effective, the proposed mindfulness intervention will target a broader range of psychological and physical symptoms, and reduce the negative impact of PPA on mothers and their infants in Canada and beyond.

Recruiting
Has No Placebo

Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton (+1 Sites)

Sheryl M Green, Ph.D., C.Psych

Image of Stanford Digestive Health Clinic in Redwood City, United States.

MITI-001 for Irritable Bowel Syndrome

18 - 65
All Sexes
Redwood City, CA

While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and/or perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms. MITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.

Phase < 1
Waitlist Available

Stanford Digestive Health Clinic (+1 Sites)

Sean P Spencer, MD, PhD

Image of Cedars-Sinai Medical Center in Los Angeles, United States.

Living Well Program for Anxiety in Breast Cancer

18+
Female
Los Angeles, CA

The goal of this study is to evaluate the efficacy and cost-effectiveness of the Living Well Program, a digital therapeutic application with telecoaching support, in breast cancer patients with moderate-to-severe anxiety. The main question the study aims to answer is: does digital cognitive-behavioral therapy-based interventions decrease the overall healthcare costs of patients with stage II to IV breast cancer? The study has one group of participants who will use the Living Well app and telecoaching support. This group will be compared to retroactively matched controls. Over 3 months, patients will complete 21 mental health modules and 5 telecoaching sessions. In the following 3 months, they will complete any outstanding telecoaching sessions and modules while still being monitored, even if they finished all modules and sessions in the first 3 months. The 6 months after that will be the follow-up phase. They will still have access to the Living Well app and may continue to use it, and they will complete the same assessment questionnaires as baseline to identify any changes in their overall mental health.

Waitlist Available
Has No Placebo

Cedars-Sinai Medical Center

Scott Irwin, MD

Have you considered Limbitrol clinical trials?

We made a collection of clinical trials featuring Limbitrol, we think they might fit your search criteria.
Go to Trials