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 imipramine 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. Imipramine 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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TOFRANIL SUMMARY
Tofranil®
imipramine hydrochloride tablets USP
(10 mg, 25 mg, and 50 mg)
Tofranil, imipramine hydrochloride USP, the original tricyclic antidepressant, is available in ampuls for intramuscular administration.
Tofranil (imipramine) is indicated for the following:
Depression: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
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NEWS HIGHLIGHTS
Published Studies Related to Tofranil (Imipramine)
Comparison between imipramine and imipramine combined with pseudoephedrine in 5-12-year-old children with uncomplicated enuresis: a double-blind clinical trial. [2011.02]
OBJECTIVE: Monosymptomatic nocturnal enuresis is a common entity, with a prevalence of 10% at the age of 7 years. For its primary treatment, we compared the effect of combination medical therapy (imipramine with pseudoephedrine) with imipramine alone... CONCLUSION: The additive pharmacologic effects of imipramine with pseudoephedrine for the treatment of monosymptomatic nocturnal enuresis in children were well tolerated, and gave significantly faster results than single drug therapy using imipramine. The moderate-to-high recurrence rate following discontinuation of medical treatment indicates the need for a longer term study involving more cases. Crown Copyright (c) 2010. Published by Elsevier Ltd. All rights reserved.
Comparison between imipramine and imipramine combined with pseudoephedrine in
5-12-year-old children with uncomplicated enuresis: a double-blind clinical
trial. [2011]
imipramine alone... CONCLUSION: The additive pharmacologic effects of imipramine with pseudoephedrine
Serum zinc level in depressed patients during zinc supplementation of imipramine treatment. [2010.11]
BACKGROUND: Recurrent major depression is associated with decreased blood zinc concentrations that may be increased by effective antidepressant therapy. Some clinical investigations point to alterations of the zinc level in blood as a potential marker of depression... CONCLUSIONS: Serum zinc is a state marker of depression. Copyright (c) 2010 Elsevier B.V. All rights reserved.
Low-dose gabapentin as useful adjuvant to opioids for neuropathic cancer pain when combined with low-dose imipramine. [2010.06]
PURPOSE: Painful neuropathic conditions of cancer pain often show little response to nonopioid and opioid analgesics but may be eased by antidepressants and anticonvulsants. Although gabapentin is effective in the treatment of neuropathic pain in patients with cancer, some patients experience intolerable side effects sufficient to warrant discontinuation. The aim of this study was to see whether low-dose gabapentin is effective in treating cancer-related neuropathic pain when combined with low-dose imipramine... CONCLUSION: Low-dose gabapentin-antidepressant combination with opioids was effective in managing neuropathic cancer pain without severe adverse effects.
Treatment of unipolar psychotic depression: a randomized, double-blind study comparing imipramine, venlafaxine, and venlafaxine plus quetiapine. [2010.03]
CONCLUSION: That unipolar psychotic depression should be treated with a combination of an antidepressant and an antipsychotic and not with an antidepressant alone, can be considered evidence based with regard to venlafaxine-quetiapine vs. venlafaxine monotherapy. Whether this is also the case for imipramine monotherapy is likely, but cannot be concluded from the data.
Clinical Trials Related to Tofranil (Imipramine)
Imipramine and Pregabalin Combination in Painful Polyneuropathy [Not yet recruiting]
Polyneuropathy of different etiologies is often associated with pain and the standard
treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this
study is that the combination of the gabapentinoid pregabalin and the antidepressant
imipramine will provide better pain relief than the single compounds alone.
This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of
pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study
will include 60 patients and the treatment outcome will be pain intensity as measured by
numeric rating scales.
Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome [Recruiting]
The aim of this study is to test the effect of the tricyclic antidepressant Imipramine in
patients with longlasting health problems with no known medical explanation, defined as
multi-organ Bodily distress syndrome (BDS). Pharmacological treatment of patients with BDS
have never been tested, and Imipramine i low dosage (10-75 mg) has the potential of reducing
both pain and other symptoms of bodily distress for patients with BDS. Control conditions
are pill placebo. Study duration is 19 weeks for each of the 140 patients.
The Efficacy of Imipramine in Treatment of Functional Dyspepsia [Recruiting]
The aim of this study is evaluate the efficacy of Imipramine, a tricyclic antidepressant, in
treatment of functional dyspepsia. This is a double blind randomised placebo controlled
trial in which consecutive patients with diagnosis of functional dyspepsia will be studied.
After exclusion of organic cause of dyspepsia by endoscopy, these patients will be randomly
assigned to either imipramine or placebo. All the patients will enter an additional 4 weeks
of drug withdrawal phase after the initial 12 weeks of study drug treatment. They will be
evaluated for treatment response, which is defined as satisfactory relief of dyspeptic
symptoms at the end of 12-week treatment.
Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn [Recruiting]
Esophageal hypersensitivity/Functional heartburn are common among non-erosive reflux disease
(NERD) patients who do not response to proton pump inhibitors. Whether tricyclic
antidepressant improves NERD patient's symptoms remains unknown
Aim of this randomized controlled trial study is to determine the efficacy of imipramine,
which could increase esophageal pain thresholds in healthy volunteers, in comparison with
placebo for treatment patients with esophageal hypersensitivity or functional heartburn
evaluated by improvement of specific-symptom score and quality of life
Antidepressant Treatment of AIDS Related Depression. [Completed]
To test the effectiveness treating AIDS related depression with imipramine hydrochloride.
Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due
to the relentless course of HIV infection, there is a certain reluctance to treat the
associated depression. In other illness, it has been proven that treating the depression
often results in improvement of overall health status.
This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride
every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating
Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over
phase in which placebo non responders are entered into an open-label study and given
imipramine hydrochloride.
Reports of Suspected Tofranil (Imipramine) Side Effects
Confusional State (7),
Bipolar Disorder (6),
Somnolence (5),
Weight Increased (4),
Fatigue (4),
Agitation (3),
Drug Ineffective (3),
Chronic Obstructive Pulmonary Disease (3),
Mania (3),
Dyspepsia (3), more >>
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Page last updated: 2013-02-10
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