Elavil (Amitriptyline) - Summary

ELAVIL SUMMARY

ELAVIL (amitriptyline hydrochloride) is an antidepressant drug of the tricyclic type. ELAVIL is an antidepressant with sedative effects. Its mechanism of action in man is not known. It is not a monoamine oxidase inhibitor and it does not act primarily by stimulation of the central nervous system.

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

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NEWS HIGHLIGHTS

Media Articles Related to Elavil (Amitriptyline)

Quality Of Life And Symptoms Rapidly And Significantly Improved By Non-Drug Depression Treatment
Source: Anxiety / Stress News From Medical News Today [2012.05.10]
New data released at the annual meeting of the American Psychiatric Association show that patients with unipolar, non-psychotic Major Depressive Disorder (MDD) receiving transcranial magnetic stimulation (TMS) with NeuroStar TMS Therapy® achieved significant improvements in both depression symptoms and in quality of life measurements...

Depression - How Effective Is Collaborative Care Intervention?
Source: Depression News From Medical News Today [2012.05.09]
A study published in the May issue of Archives of General Psychiatry, reveals that individuals with depression and poorly controlled diabetes mellitus, coronary heart disease, or both, can benefit from a collaborative care intervention...

Late-Life Depression May Signal Alzheimer's Disease; Lifelong Depression May Increase Risk Of Vascular Dementia
Source: Depression News From Medical News Today [2012.05.09]
Depressive symptoms that occur in both midlife and late life are associated with an increased risk of developing vascular dementia, while symptoms that occur in late life only are more likely to be early signs of Alzheimer's disease, according to University of California at San Francisco and Kaiser Permanente researchers...

Middle Aged And Elderly With Depression Have Higher Risk Of Dementia
Source: Depression News From Medical News Today [2012.05.08]
A report in the May issue of Archives of General Psychiatry draws a link between people in mid-life and late-life, suffering from depression and the possibility of them developing dementia. More than five million people in the US alone suffer from Alzheimer's disease, and the health care costs run at a staggering $172 Billion. Deborah E. Barnes, Ph.D., M.P.H...

Study Links Late Depression, Risk of Dementia (CME/CE)
Source: MedPage Today Neurology [2012.05.08]
(MedPage Today) -- Depression that strikes for the first time in later life may be an early sign of Alzheimer's disease, researchers reported, but depression in the middle years that recurs later may be one of the causes of vascular dementia.

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Published Studies Related to Elavil (Amitriptyline)

Randomised clinical trial: the effects of amitriptyline on drinking capacity and symptoms in patients with functional dyspepsia, a double-blind placebo-controlled study. [2011.09]
BACKGROUND: Functional dyspepsia is one of the most prevalent (15-40%) functional gastrointestinal disorders. Antidepressants such as amitriptyline are often used in these patients, but clinical studies are currently lacking. AIM: To evaluate the effect of 8 weeks of treatment with amitriptyline on drinking capacity, symptoms evoked by a standardised drink test (primary endpoint) and clinical symptoms (secondary endpoint)... CONCLUSIONS: Amitriptyline did not affect drinking capacity and postprandial symptoms evoked by the drink test in FD patients. However, total clinical symptom score and nausea were reduced during 8 weeks of treatment. Our data suggest that amitriptyline particularly improves nausea in functional dyspepsia, but larger clinical trials are needed to further confirm our findings. (c) 2011 Blackwell Publishing Ltd.

Development of amitriptyline buccoadhesive tablets for management of pain in dental procedures. [2011.07]
Administration of lidocaine and nonsteroidal anti-inflammatory drugs (NSAIDs) as a routine procedure for relief of dental pains by and large is restricted due to some side effects. Amitriptyline (AM) has long been known to exert analgesic activity as a result of blocking the Na channels... It is suggested that applying the topical AM mucoadhesive tablet containing the low amount of drug is a safe and promising alternative to relief the pain in the buccal region.

Effect of intravenous lidocaine associated with amitriptyline on pain relief and plasma serotonin, norepinephrine, and dopamine concentrations in fibromyalgia. [2011.05]
OBJECTIVE: The objective of this study was to evaluate the effect of intravenous lidocaine combined with amitriptyline on pain relief and plasma serotonin, norepinephrine, and dopamine levels... CONCLUSIONS: Combined administration of 240 mg intravenous lidocaine (once a week) and 25 mg amitriptyline for 4 weeks did not modify pain intensity or plasma serotonin, norepinephrine, or dopamine concentrations in fibromyalgia patients.

A comparative evaluation of amitriptyline and duloxetine in painful diabetic neuropathy: a randomized, double-blind, cross-over clinical trial. [2011.04]
CONCLUSIONS: Both duloxetine and amitriptyline demonstrated similar efficacy in PDN. A large, multicentric clinical trial in other populations could possibly demonstrate the superiority of either drug.

Amitriptyline in the prophylactic treatment of migraine and chronic daily headache. [2011.01]
OBJECTIVE AND BACKGROUND: Amitriptyline is one of the most commonly used medications in migraine prophylaxis. There have been relatively few placebo-controlled studies of amitriptyline in migraine prophylaxis or in treatment of chronic daily headache (CDH). This report deals with a large placebo-controlled trial of amitriptyline vs placebo of 20 weeks duration that included subjects with intermittent migraine (IM) as well as CDH. The study was carried out between 1976 and 1979; however, results have never been fully reported... CONCLUSIONS: In this study, using headache frequency as the primary metric, for the entire group, amitriptyline was superior to placebo in migraine prophylaxis at 8 weeks but, because of a robust placebo response, not at subsequent time points. For the subgroup with CDH, amitriptyline was statistically significantly superior to placebo at 8 weeks and 16 weeks with a similar but nonsignificant trend at 12 and 20 weeks. Compared with placebo amitriptyline is effective in CDH. Amitriptyline was also significantly effective in IM compared intragroup to its own baseline; however, placebo was equally effective in the same analysis. The reason for the robust placebo response in the IM group is not clear, but has been occasionally reported. (c) 2010 American Headache Society.

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Clinical Trials Related to Elavil (Amitriptyline)

Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy [Recruiting]

Combining N-of-1 Trials to Assess Fibromyalgia Treatments [Completed]
This study will compare the effectiveness of combination therapy with the drugs amitriptyline and fluoxetine (AM+FL) and amitriptyline (AM) alone in the treatment of people with fibromyalgia. Doctors will treat each study participant with both AM + FL and AM alone for 6 weeks at a time. The study uses a method that combines results from treatment of individual patients to assess overall treatment effectiveness and help individual patients and their physicians with their treatment decisions. This study will also help compare the results of community-based studies (studies involving private doctors) and studies based at clinical research centers.

Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer [Recruiting]
Rationale: Often, incurable cancer patients suffer from severe symptoms as (neuropathic) pain and fatigue with polypharmaceutic interventions as a consequence. Regarding neuropathic pain in incurable cancer patients, pregabalin has been registered for neuropathic non-cancer pain, and amitriptyline is not registered for neuropathic pain, but is recommended as the drug of first choice in the Dutch handbooks of palliative care. As a consequence of an adaptation of a Dutch law (July 2007) about off-label medication prescription, off-label medication is not allowed anymore unless a standard or protocol exists. No clinical trials for this patient group have been published before.

Objective: To compare efficacy, side effects and costs of a strategy with amitriptyline as drug of first choice versus a strategy with pregabalin as drug of first choice.

Study design: An open label, randomised non-inferiority trial Study population: Incurable cancer patients with neuropathic pain Intervention: When a patient decides to take part in the study, he will be allocated randomly to one of the two study groups. A minimisation algorithm will be used, that balances for the cause of neuropathic pain (tumour related versus treatment related), type of treatment (ongoing chemo- or radiotherapy versus not ongoing chemo- or radiotherapy) and institution. Each drug will be prescribed in a step up procedure. Patients will be followed during 8 weeks.

Main study parameters/endpoints: Neuropathic pain, as measured with the mean VAS and McGill questionnaire, strategy success, costs per strategy, side effects, quality of life and concomitant analgesic drugs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are hardly any risks for the patients. The drugs in both arms already are usual care for the target population. If there is no or a too small effect, the drug of the other arm will be added, which strategy also is already usual care. All other medication, except for Tricyclic Antidepressants Drugs (TADs) and Anti Epileptic Drugs (AEDs), as well as radiotherapy and chemotherapy are allowed. The patient has to visit the hospital 2 times during the study period. The patient had to fill in a pain diary daily (5 min), cost diary and EQ-5D every other week (10 min), related questionnaires as HADS, McGill and EORTC-QLQ-C30 monthly (20 min).

Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 4 Years of Age [Recruiting]
Gastrojejunal (G-J) feeding tubes are placed in infants and children who refuse to eat or are unable to eat enough to have normal growth. Although often intended as temporary short-term solutions to medical complications, feeding tubes can become a permanent method for eating.

While tube feeding routinely saves the lives of children who have long term food refusal, continuation of tube feeding can be hard for patients, caregivers, and families. At the current time there are few treatments for helping children move from tube to oral feeding. Some patients may be treated with the help of inpatient programs such as a combination of medical and behavioral techniques to train children to eat orally. These programs typically require hospital stays of 2-4 months.

By doing the current study the investigators hope to learn if the investigational drug amitriptyline is helpful in moving children from tube to oral feeding, and to look at whether or not the treatment of pain helps with this transition.

Study With Amitriptylin to Evaluate the Efficacy of Melatonin in Treatment of Migraine [Recruiting]

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PATIENT REVIEWS / RATINGS / COMMENTS

Elavil review by 56 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Depression
Dosage & duration:		25 mg. taken daily for the period of 12 years
Other conditions:		Sleep problems
Other drugs taken:		Erythrom.
		Reported Results
Benefits:		Although this drug was originally prescribed for depression, it helped with sleeplessness. Therefore, I have continued to take it for that alone. While I still on occasion have problems falling asleep, I find I can combine it with Melatonin or Valerian. In 12 years, I haven't had to increase the elavil dosage.
Side effects:		None.
Comments:		One a day, taken about an hour before bedtime.

Elavil review by 51 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		sleep
Dosage & duration:		35mg taken once a day for the period of 22years
Other conditions:		anxiety, shy, but overal healthy
Other drugs taken:		larozepam took for 5-6 years, discontinued
		Reported Results
Benefits:		helps me fall asleep and stay asleep
Side effects:		difficult to get up, tiredness in the morning, light sensitivity, constipation
Comments:		i have been take amitriptyline for the last 22 years, without too serious side effects. i never miss a dose- if by some reason i dont have it - i will never be able to fall asleep at all. I started on 10mg but now i am taking 35mg, it helps.

Elavil review by 61 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		insomnia
Dosage & duration:		150 mg taken once for the period of once
Other conditions:		sarcoidosis
Other drugs taken:		lisinopril, theophylline, cartia, premarin
		Reported Results
Benefits:		Highly effective for sleeping.
Side effects:		Slept for 3 days. Very disoriented and groggy!
Comments:		not exactly what I had in mind. I wake up during the night at 2 or 3 or 4 am and am unable to go back to sleep, I wanted the ability to sleep through the night. But I did not want to sleep for 3 days! I think maybe the initial dose was too high. I only took one tablet and never took another one.