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 HIGHLIGHTS
Published Studies Related to Nortriptyline
Nortriptyline for treating enuresis in ADHD--a randomized double-blind controlled
clinical trial. [2012]
enuresis in children with ADHD... CONCLUSIONS: Administration of nortriptyline for treating enuresis in ADHD has
Topiramate plus nortriptyline in the preventive treatment of migraine: a controlled study for nonresponders. [2011.10.19]
A sizeable proportion of migraineurs in need of preventive therapy do not significantly benefit from monotherapy. The objective of the study is to conduct a randomized controlled trial testing whether combination therapy of topiramate and nortriptyline is useful in patients who had less than 50% decrease in headache frequency with the use of the single agents...
Melancholic, atypical and anxious depression subtypes and outcome of treatment with escitalopram and nortriptyline. [2011.07]
CONCLUSIONS: Melancholic, atypical or anxious depression, are not sufficiently robust differential predictors of outcome to help clinician choose between SSRI and tricyclic antidepressants. There is a need to investigate other predictors of outcome. Copyright (c) 2011 Elsevier B.V. All rights reserved.
Genetic variants in the serotonin transporter influence the efficacy of bupropion and nortriptyline in smoking cessation. [2011.06.09]
Aims We investigated whether variants in the serotonin transporter gene (SLC6A4) influence smoking cessation rates using antidepressant therapy (i.e.Prospective studies have to assess if this can improve cessation rates when treatment is targeted at individuals based on their genotypes.
A double-blind randomized controlled trial of low doses of propranolol, nortriptyline, and the combination of propranolol and nortriptyline for the preventive treatment of migraine. [2009.12]
Few trials have evaluated combination of two or more drugs in the preventive treatment of migraine. In this study three therapeutic regimens were compared: (a) propranolol, at a dose of 40 mg per day, (b) nortriptyline, at a dose of 20 mg per day, and (c) the combination of these two drugs in these dosages...
Clinical Trials Related to Nortriptyline
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.
Relapse Prevention With Escitalopram or Nortriptyline Following Electro-Convulsive Treatment (DUAG-7) [Recruiting]
The main purpose of this study is to investigate the relapse preventing efficacy of
escitalopram in a dose range and nortriptylin in a single dose in patients having been
treated successfully with a course of electroconvulsive treatment (ECT).
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.
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 8 ratings/reviews, Nortriptyline has an overall score of 6.88. The effectiveness score is 8.25 and the side effect score is 7.25. 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 21 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | migraines |
| Dosage & duration: | | 50mg taken at night for the period of 4 months |
| Other conditions: | | n/a |
| Other drugs taken: | | nuvaring | | |
Reported Results |
| Benefits: | | I had migraines everyday, this slowly worked it up to where i'd only get a mild migraine once maybe twice a week at most. |
| Side effects: | | I lost 10 lbs over the course of 4 months, my ears hurt and sounded more muffled, my glands in my throat swelled but don't hurt. I had HORRIBLE dry cotton mouth in the morning, when i got to the 50mg of the medicine my heart rate was 144 hr. My insomnia got worse but even though i wasn't sleeping as well, i wasn't ever tired. |
| Comments: | | started at 10mg and worked my way up to 50mg weekly, the side effects got worse as the dose got higher. |
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| | Nortriptyline review by 28 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | a typical migraines |
| Dosage & duration: | | 25mg upped to 75 mg taken 1 at bedtime for the period of just over a week |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I have A-typical migraines which gives me weird sensation in my ears such as roaring and the sense that they are vibrating. I also do have headacheds that seem to come from ears and the back of my neck. It help me feel better and started to decrease my symptoms but side effects were worse than original symptoms. It helped me to ignore my symptoms and helped me to get through the day. |
| Side effects: | | ringing in the ears, sensitivity to noise, phantom noise in head, which all lead to anxiety |
| Comments: | | stopped medicine, looking for something else to help. |
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Page last updated: 2013-02-10
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