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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 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 is 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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PAMELOR SUMMARY
Pamelor® (nortriptyline HCl) is a tricyclic antidepressant.
Pamelor® (nortriptyline HCl) 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 Pamelor (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 Pamelor (Nortriptyline)
Nortriptyline for Idiopathic Gastroparesis [Completed]
The principal objective of this multicenter, randomized, placebo-controlled trial is to
evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared
with placebo.
Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia [Terminated]
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.
Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine [Recruiting]
The investigators' study plans to randomize treatment naive patients with vestibular
migraine to an 8 week trial of an escalating dose of either nortriptyline or topiramate
followed by an 8 week crossover to the other drug if patient is willing, if patient wants to
stay on first medication we will just continue to follow. During the first 8 weeks if there
is an intolerance to the first drug they can be switched to the other drug at any point and
then followed on that medication for the remainder of the study. Response to therapy will be
quantified by the Migraine Specific Quality of Life (MSQ) and Dizziness Handicap Inventory
(DHI) administered at multiple time points during the study. Three groups of patients that
will be eligible for the study will include 1)Patients with Neuhauser dVM; 2)Patients with
pVM; and 3) Patients with dizziness that falls outside the Neuhauser criteria (non-Neuhauser
vestibular migraine or nNVM).
The investigators' hypothesis is that even patients with dizziness outside of the Neuhauser
dVM and pVM spectrum will respond to treatment for vestibular migraine, and thus likely have
migraine as a cause of their dizziness. Previous research by our group has suggested that
such patients do in fact respond to migraine therapy1. A second goal of the study is to
evaluate the comparative efficacy of nortriptyline and topiramate in the treatment of these
three subgroups of patients with vestibular migraine.
Effect of Nortriptyline in Cortical Representation of Heartburn in Nonerosive Reflux Disease (NERD) Patients [Completed]
Patients with nonerosive reflux disease (NERD) are less responsive to standard treatment
with proton pump inhibitors. The hypothesis of this study was that nortriptyline in
analgesic doses may decrease heartburn perception and its corresponding cortical activity
measured by magnetic resonance image. Therefore, the aim of this study was to assess the
cortical representation of heartburn in patients with NERD under treatment with
nortriptyline and placebo.
Treatment of Depression in Parkinson's Disease Trial [Completed]
The goal of this study is to evaluate the effectiveness and safety of two
antidepressants--nortriptyline and paroxetine, compared to placebo in patients with
Parkinson's disease and depression.
Reports of Suspected Pamelor (Nortriptyline) Side Effects
Drug Ineffective (16),
Weight Increased (8),
Thrombosis (7),
Headache (7),
Oedema Peripheral (7),
Rash (7),
Agitation (6),
Somnolence (6),
Fatigue (6),
Drug Hypersensitivity (6), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Pamelor has an overall score of 7. The effectiveness score is 9 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
| | Pamelor review by 30 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 10-50mg taken daily for the period of 18 months |
| Other conditions: | | facial nerve pain, migraines, upper back pain |
| Other drugs taken: | | topamax (topiramate) | | |
Reported Results |
| Benefits: | | This medication was greatly effective in alleviating my depression, more effective than SSRIs or SNRIs I have tried. Also, the effects did not seem to wear off with time (over the course of treatment, 9-12 months) which I experienced with celexa and effexor xr. The facial pain was also decreased, this medication is also used as a treatment for nerve pain. |
| Side effects: | | One of the most unfortunate side effects of all tricyclic antidepressants for many people is weight gain. I was 'lucky' that I did not gain weight, but I was almost totally unable to lose weight despite diligent nutrition and exercise.
The medication also increased my heart rate. I was unable to take it at night (which is the common prescribing practice) as the accelerated heart rate would keep me awake. Taking it in the AM seemed to work around this problem but may have caused some daytime fatigue/sleepiness (this is why is it usually prescribed to be taken at night). |
| Comments: | | I began at 10mg then worked up to a 50mg dose. I had relatively good suppression of depressive symptoms at all doses, higher doses being better. The higher doses did not seem to increase the weight gain/heart rate side effects any more than the lower doses (as in non-dose-dependent effects).
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| | Pamelor review by 44 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | musle relaxant |
| Dosage & duration: | | 40mg taken every night for the period of 5years |
| Other conditions: | | generaly healthy |
| Other drugs taken: | | nothing | | |
Reported Results |
| Benefits: | | As I was able to relax my headache almost disappeared. The headache was due to stiff jaw syndrome. The symptoms should ease after two months but I feel relief the first day I start taking medicine. I was able to concentrate again and the most important I did not feel tired. |
| Side effects: | | I felt sleepy. I put about 3kg weight. After 2 months side effects ease and then disappeared. |
| Comments: | | take 40mg of the medicine every night before slip. |
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Page last updated: 2013-02-10
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