Tofranil (Imipramine Hydrochloride) - Summary

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)

A randomized controlled trial of imipramine in patients with irritable bowel syndrome. [2009.08.07]
AIM: To study the efficacy of low-dose imipramine in relieving symptoms associated with the irritable bowel syndrome (IBS)... CONCLUSION: Imipramine may be effective in the treatment of IBS patients and is associated with improved QoL. Careful patient selection, initiation of a low dose with gradual escalation and monitoring for side effects may result in an improved therapeutic response.

Fluoxetine and imipramine: are there differences in cost-utility for depression in primary care? [2009.02]
RATIONALE: Depressive disorders generate severe personal burden and high economic costs. Cost-utility analyses of the different therapeutical options are crucial to policy-makers and clinicians. Previous cost-utility studies, comparing selective serotonin reuptake inhibitors and tricyclic antidepressants, have used modelling techniques or have not included indirect costs in the economic analyses. OBJECTIVE: To determine the cost-utility of fluoxetine compared with imipramine for treating depressive disorders in primary care... CONCLUSION: Imipramine seems to be a better cost-utility antidepressant option for treating depressive disorders in primary care.

Treatment of Panic Disorder with Agoraphobia: Randomized Placebo-Controlled Trial of Four Psychosocial Treatments Combined with Imipramine or Placebo. [2008.06.13]
Few randomized controlled trials have included panic disorder patients with moderate to severe agoraphobia. Therefore, this population was studied using pharmacotherapy as well as psychotherapy... This would make it possible to assess the relative efficacy of the treatment components rather than of the intervention as a whole.

Antidepressant therapy (imipramine and citalopram) for irritable bowel syndrome: a double-blind, randomized, placebo-controlled trial. [2008.01]
BACKGROUND: The efficacy of antidepressants in irritable bowel syndrome (IBS) is controversial. No trials have directly compared a tricyclic with a selective serotonin reuptake inhibitor. Our aim was to determine whether imipramine and citalopram are efficacious in IBS... CONCLUSION: Neither imipramine nor citalopram significantly improved global IBS endpoints over placebo.

Treatment of panic disorder with agoraphobia: randomized placebo-controlled trial of four psychosocial treatments combined with imipramine or placebo. [2008]
Few randomized controlled trials have included panic disorder patients with moderate to severe agoraphobia. Therefore, this population was studied using pharmacotherapy as well as psychotherapy... This would make it possible to assess the relative efficacy of the treatment components rather than of the intervention as a whole.

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Clinical Trials Related to Tofranil (Imipramine)

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.

The Effect of Imipramine on Early Information Processing [Active, not recruiting]
We wanted to compare the relation of two different psychophysiological paradigms (PrePulse Inhibition of the startle response = PPI and P50 suppression) to each other. Additionally, we wanted to test the effect of the combined serotonin- and noradrenaline re-uptake inhibitor, imipramine, on these measures. The primary hypothesis was that PPI and P50 gating would not correlate with each other at baseline. The secondary hypothesis was that increased noradrenergic and serotonergic activity would disrupt PPI as well as P50 gating.

Zinc Supplementation of Imipramine Therapy [Completed]

Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy [Completed]
Approximately 75,000-150,000 patients each year in the United States undergo intensive cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings. These patients often have high levels of disability and suffering and account for $250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of training in pain coping skills and cognitive-behavioral therapy (CBT) both produce short-term reductions in pain intensity. However, no studies have compared the effects of these two treatments on measures of pain, suffering, and disability at post-treatment and over a one-year follow-up period.

Our investigation is a 16-week, randomized controlled outcome study of these interventions and their respective placebo control procedures. One hundred and sixty patients are being recruited for this study. We will assess the effects of our interventions on patients' pain levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our treatment effects as well as their statistical significance.

The Efficacy of Imipramine in Treatment of Functional Dyspepsia: A Double Blind Randomized Placebo Controlled Trial [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.

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