Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nortriptyline hydrochloride capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nortriptyline hydrochloride capsules are not approved for use in pediatric patients. (See WARNINGS, Clinical Worsening and Suicide Risk, PRECAUTIONS, Information for Patients, and PRECAUTIONS, Pediatric Use.)
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NORTRIPTYLINE SUMMARY
NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP
Rx only
Nortriptyline hydrochloride is 1-Propanamine, 3-(10,11-dihydro-5 H -dibenzo[ a,d ]cyclohepten-5-ylidene)- N -methyl-, hydrochloride.
Nortriptyline hydrochloride is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
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NEWS HIGHLIGHTSMedia Articles Related to Nortriptyline
Promising Results In Reducing Neuropathic Pain With Combined Drug Treatment, Than With Either Drug Alone Source: Body Aches News From Medical News Today [2009.09.30] An article published Online First and in a future edition of The Lancet reports that combination treatment using gabapentin and nortriptyline reduces neuropathic pain more than either drug alone. This treatment could be used in patients that only partly respond to one drug or the other. The article is the work of Professor Ian Gilron, Director of Clinical Pain Research, Queen's University, and Kingston General Hospital, Kingston, Ontario, Canada, and colleagues.
Published Studies Related to Nortriptyline
Sensory complaints of the upper extremities in multiple sclerosis: relative efficacy of nortriptyline and transcutaneous electrical nerve stimulation. [2009.05] OBJECTIVE: The aim of this study was to evaluate the relative efficacy of nortriptyline and self-applied transcutaneous electrical nerve stimulation (TENS) in the treatment of pain and/or sensory complaints of the upper extremities in people with multiple sclerosis (MS)... This modest reduction in the intensity of pain and/or sensory complaints suggests that physicians should carefully weigh the risk and benefits of nortriptyline and TENS in people with MS with pain and/or sensory complaints.
Sexual function in postpartum women treated for depression: results from a randomized trial of nortriptyline versus sertraline. [2009.03] CONCLUSIONS: In postpartum women, sexual concerns are primarily affected by remission of depression rather than side effects of either a tricyclic or serotonergic antidepressant.
Differential efficacy of escitalopram and nortriptyline on dimensional measures of depression. [2009.03] CONCLUSIONS: The three symptom dimensions provided sensitive descriptors of differential antidepressant response and enabled identification of drug-specific effects.
[Association between polymorphisms of Val66Met in the BDNF gene and the response to escitalopram and nortriptyline treatment in the light of the neurodevelopmental hypothesis of depression] [2008.11] CONCLUSIONS: The polymorphism of the BDNF gene is not likely to be associated with treatment response to escitalopram and nortriptyline in our group of patients with depression.
Nortriptyline plus nicotine replacement versus placebo plus nicotine replacement for smoking cessation: pragmatic randomised controlled trial. [2008.05.31] OBJECTIVE: To test the efficacy of nortriptyline plus nicotine replacement therapy compared with placebo plus nicotine replacement therapy for smoking cessation... CONCLUSIONS: Nortriptyline and nicotine replacement therapy are both effective for smoking cessation but the effect of the combination is less than either alone and evidence is lacking that combination treatment is more effective than either alone. Trial registration Current Controlled Trials ISRCTN57852484.
Clinical Trials Related to Nortriptyline
Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia [Recruiting]
The purpose of this study is to determine if use of Nortriptyline will improve symptoms and
quality of life in patients who have nonulcer dyspepsia.
Nortriptyline for Idiopathic Gastroparesis [Recruiting]
The principal objective of this multicenter, randomized, placebo-controlled trial is to
evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared
with placebo.
Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation [Completed]
Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco
withdrawal symptoms and increases long term cessation rates when combined with transdermal
nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized,
parallel group trial in which smokers aged 18-70 will be subject to the combination of oral
and patch treatments.
Preventing the Return of Depression in Elderly Patients [Completed]
The purpose of this study is to compare the effectiveness of two doses of nortriptyline in
elderly patients whose depression returned after stopping treatment. Nortriptyline is an
antidepressant.
This study enrolls patients who were treated for depression in an earlier research study and
whose depression has returned since stopping treatment. Patients are treated for 4 months to
bring the depression under control. Patients are then assigned randomly (like tossing a
coin) to receive either the full dose of nortriptyline or half the usual dose of
nortriptyline. Patients continue taking nortriptyline for 2 years or until a major
depression returns. Throughout the study, patients are monitored for symptoms of depression
and other side effects.
Pain Treatment for Sciatica [Completed]
This study will test the effectiveness of two drugs-nortriptyline and MS Contin (a type of
morphine)-to treat pain caused by lumbar radiculopathy, or sciatica. Sciatica results from
damage to the lumbar nerve roots, typically causing back pain and sharp, shooting pain down
one or both legs. Although sciatica is common, there are no good treatments for it.
Tricyclic antidepressants, such as nortriptyline, and opioids, such as morphine, have been
effective in treating other kinds of pain from nerve damage.
Patients between 18 and 65 years of age who have had sciatica pain daily for at least 3
months may be eligible for this study.
Participants will provide a medical history and occupational and other social information.
They will undergo a neurological examination, routine blood tests and an electrocardiogram
and will fill out three questionnaires providing information on daily functioning and
psychological well-being.
This "cross-over" study consists of several parts, including a baseline study and four
different treatment regimens. During each part, patients keep a daily log in which they rate
their pain, record other procedures they undergo, such as injections and manipulations, and
record medication side effects.
In the first week of the study, patients remain on their current medications. Any
antidepressants or opioids are stopped gradually before starting the drug trials. After the
first week, patients go through the following four drug trials in random order:
1. Nortriptyline and inert placebo-Patients take nortriptyline in doses ranging from 25 mg.
to 100 mg. and an inert placebo for morphine. (An inert placebo is a dummy pill; it
looks like the test drug but has no active ingredient.)
2. MS Contin (morphine) and inert placebo-Patients take MS Contin in doses ranging from 30
mg. to 90 mg. and an inert placebo for nortriptyline.
3. Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose
ranges as for each drug alone.
4. Active placebo and inactive placebo-Patients take an active placebo-in this case
benztropine-and an inert placebo. An active placebo is a drug that does not work for
the problem being studied but whose side effects are like those of the test drug-in this
case, slight sleepiness or dry mouth. Benztropine is given at one-third the recommended
dosage.
For each drug regimen, the medication dose is increased gradually over 5 weeks until the
maximum tolerated dose is reached. At the end of each regimen, patients are taken off the
study drugs over a 12-day tapering period and are off drugs completely for another 2 days.
Patients are seen by a doctor or nurse at the 7-week point in each study period. After all
the drug trials are finished, patients repeat the questionnaires they filled out at the
beginning of the study. Patients and their doctors will be informed of the medications that
were effective in each individual's care.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 4 ratings/reviews, Nortriptyline has an overall score of 8.25. The effectiveness score is 9 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Nortriptyline review by 41 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | | Treatment Info |
| Condition / reason: | | joint/muscular issues - fibro |
| Dosage & duration: | | 25mg taken once a day for the period of 5 years |
| Other conditions: | | sleep issues due to pain but was alleviated by meds |
| Other drugs taken: | | advil for occassional pain during the day | | | Reported Results |
| Benefits: | | ability to sleep though the night decreasing joint/muscle pain and cramps allowing for a more productive day |
| Side effects: | | none once proper dosages were found....higher mg's made me "foggy" |
| Comments: | | when I was not able to sleep the pain would increase which would lead to a cycle of not being able to sleep as I could not relax..the meds would help me to sleep which would allow my body to relax - this in turn led to a decrease in my symptoms..though there were still times when this would not be effective, such as if I was under high levels of stress or could not get 8 hours of sleep..if the condition continued for to long, severe depression, weepiness and other symptoms would begin to appear - usually a week of prescription sleep aides would help "re-set" my system and we could get back to the original program. |
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| | Nortriptyline review by 43 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | | Treatment Info |
| Condition / reason: | | shooting nerve-type pain in legs/fibromyalgia |
| Dosage & duration: | | 25 mg per day taken once at night for the period of 2 years |
| Other conditions: | | fibromyalgia, neuralgia |
| Other drugs taken: | | none | | | Reported Results |
| Benefits: | |
the excruciating, shooting nerve pain in my left leg stopped after about a week although I could still feel that the nortriptyline just masked the pain ie. In the past 6 months I have got down to 12.5 mg per day although a recurrence of the terrible shooting pain (after 2 years) had made me decide to try Gabapentin instead- my doc recommends this |
| Side effects: | | Fuzziness of thinking/short term memory loss- although this might be due to my fibromyalgia. Sexual disfunction- ie inability to have a full orgasm- and after 2 years of this, thi sis one of the reasons why I am ready to change to Gabapentin- as recommended by my doc. Sleepiness etc goes away after the first few weeks although it took me a good 6 months to properly adapt to this drug |
| Comments: | | 10mg at night for the first 6 months, then the pain came through again so I upped this to 25mg per day. Six months ago, I wasn;t aware of any pain behind the pain that I had been used to so, thinking I was maybe a bit better, I cut the intake down to 12.5 mg a day by cutting my 25mg tablet in half each night. this was fine until a week ago when the shocking shooting pain returned accompanied by pin-prick sensations on my face and on my limbs- I've not had thi sin 2 years. I intend to try gabapentin now, although some people have referred to it as the 'zombie drug'. My main reason for not upping the Nortrip back to 25mg, is that I want to see if I will be able to have an orgasm on the Gaba- although maybe this is a luxury- as anyone with nerve pain knows, sex is the last thing on your mind when you are in such pain. But who knows, maybe I will be able to be pain-free and get my libido back...! |
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| | Nortriptyline review by 43 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | | Treatment Info |
| Condition / reason: | | shooting nerve-type pain in legs/fibromyalgia |
| Dosage & duration: | | 25 mg per day taken once at night for the period of 2 years |
| Other conditions: | | fibromyalgia, neuralgia |
| Other drugs taken: | | none | | | Reported Results |
| Benefits: | |
the excruciating, shooting nerve pain in my left leg stopped after about a week although I could still feel that the nortriptyline just masked the pain ie. In the past 6 months I have got down to 12.5 mg per day although a recurrence of the terrible shooting pain (after 2 years) had made me decide to try Gabapentin instead- my doc recommends this |
| Side effects: | | Fuzziness of thinking/short term memory loss- although this might be due to my fibromyalgia. Sexual disfunction- ie inability to have a full orgasm- and after 2 years of this, thi sis one of the reasons why I am ready to change to Gabapentin- as recommended by my doc. Sleepiness etc goes away after the first few weeks although it took me a good 6 months to properly adapt to this drug |
| Comments: | | 10mg at night for the first 6 months, then the pain came through again so I upped this to 25mg per day. Six months ago, I wasn;t aware of any pain behind the pain that I had been used to so, thinking I was maybe a bit better, I cut the intake down to 12.5 mg a day by cutting my 25mg tablet in half each night. this was fine until a week ago when the shocking shooting pain returned accompanied by pin-prick sensations on my face and on my limbs- I've not had thi sin 2 years. I intend to try gabapentin now, although some people have referred to it as the 'zombie drug'. My main reason for not upping the Nortrip back to 25mg, is that I want to see if I will be able to have an orgasm on the Gaba- although maybe this is a luxury- as anyone with nerve pain knows, sex is the last thing on your mind when you are in such pain. But who knows, maybe I will be able to be pain-free and get my libido back...! |
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Page last updated: 2009-10-20
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