BOX WARNING 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 pamoate 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 pamoate 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-PM SUMMARY
Tofranil-PM® (imipramine pamoate capsules), is a tricyclic antidepressant, available as capsules for oral administration. The 75-, 100-, 125-, and 150-mg capsules contain imipramine pamoate equivalent to 75, 100, 125, and 150 mg of imipramine hydrochloride.
Tofranil-PM (imipramine) is indicated for the following:
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 HIGHLIGHTSMedia Articles Related to Tofranil-PM (Imipramine)
Depression As Deadly As Smoking, But Anxiety May Be Good For You
Source: Anxiety / Stress News From Medical News Today [2009.11.19]
A study by researchers at the University of Bergen, Norway, and the Institute of Psychiatry (IoP) at King's College London has found that depression is as much of a risk factor for mortality as smoking.
At-Risk College Students Reduce HBP, Anxiety, Depression Through Transcendental Meditation
Source: Anxiety / Stress News From Medical News Today [2009.11.18]
The Transcendental Meditation technique may be an effective method to reduce blood pressure, anxiety, depression, and anger among at-risk college students, according to a new study to be published in the American Journal of Hypertension, December 2009.
Symptoms Of Depression Improved By Motivational "Women-Only" Cardiac Rehab
Source: Depression News From Medical News Today [2009.11.18]
Depressive symptoms improved among women with coronary heart disease who participated in a motivationally-enhanced cardiac rehabilitation program exclusively for women, according to research presented at the American Heart Association's Scientific Sessions 2009. Depression often co-occurs with heart disease and is found more often in women with heart disease than in men.
Telephone-Delivered Care For Treating Depression After CABG Surgery Appears To Improve Outcomes
Source: Depression News From Medical News Today [2009.11.17]
Patients who received telephone-delivered collaborative care for treatment of depression after coronary artery bypass graft surgery reported greater improvement in measures of quality of life, physical functioning and mood than patients who received usual care, according to a study in the November 18 issue of JAMA. The study is being released early online because of its presentation at an American Heart Association scientific conference.
Treating depression after surgery speeds recovery (Reuters)
Source: Y! Health Depression News [2009.11.17]
Reuters - A simple telephone intervention improved mood, physical functioning, and overall quality of life in patients who were depressed after heart bypass surgery, researchers reported in a late breaking clinical trial here at the American Heart Association Scientific Sessions 2009.
Published Studies Related to Tofranil-PM (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.
Tolterodine and imipramine in refractory enuresis; a placebo-controlled crossover study. [2008.02]
The anticholinergic drug tolterodine has been suggested to be useful in therapy-resistant enuresis... Imipramine was better than placebo, but side effects were common.
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.
Clinical Trials Related to Tofranil-PM (Imipramine)
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.
Dichotic Listening as a Predictor of Medication Response in Depression [Recruiting]
This study will recruit 100 depressed patients to test whether the previous finding of an
association between treatment response (with treatment groups including placebo, imipramine,
and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also
found with a different type of commonly used anti-depressant, bupropion.
Treatment of Depression Following Multiple Brain Tests [Recruiting]
The main purpose of this study is to correlate brain testing with treatment outcome.
Assessment of Pituitary Adenylate Cyclase Activating Polypeptide-Brain Derived Neurotrophic Factor (PACAP-BDNF) Signaling System Involvement in Etiology and Treatment of Major Depression [Recruiting]
The neuropeptide Pituitary Adenylate Cyclase Activating Polypeptide (PACAP) and its
receptors PAC1 and VPAC2 are widely expressed in the nervous system. The investigators found
that PACAP treatment of neuronal cell cultures increases expression of Brain Derived
Neurotrophic Factor (BDNF) that plays an important role in the etiology of psychiatric
disorders and action of antidepressants. For the first time, the investigators demonstrated
that treatment by Paroxetine and Citalopram significantly decreases PAC1 and VPAC2 and
upregulates PACAP mRNA expression, whereas Imipramine shows an opposite effect. Moreover,
PACAP, PAC1 and VPAC2 expression is highly correlated with BDNF expression. Their in vivo
studies show that Imipramine reduces BDNF and increases PAC1 mRNA expression in murine
hippocampus, suggesting that antidepressants may affect neuronal plasticity through
PACAP-BDNF interactions. Based on their observations in experimental systems, the
investigators hypothesize that PACAP signaling system may be involved in the etiology of
depression and mechanism of antidepressant action. The investigators will evaluate this
hypothesis by examining serum PACAP levels, effect of antidepressants on PACAP levels, and
gene polymorphisms of PACAP and its receptors in major depressive disorder patients. This
study will enhance the investigators' understanding of PACAP's role in the etiology of
depression and antidepressant treatment and will provide a basis to evaluate PACAP pathway
as a potential target for diagnostics and novel antidepressants drug discovery.
Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism [Recruiting]
Reduction of volume of the hippocampus has been associated with major depression in many
studies. It has been suggested that antidepressants may protect against hippocampus volume
loss in humans associated with multiple episodes of depression and may also reverse the
reduction of volume caused by the depression. In addition, genetic markers for serotonin are
implicated with depression, and may be an indication of reduced response to antidepressant
treatments.
This study aims to enroll patients who are defined as having treatment resistant depression
(no remission after at least 2 treatments trials with an antidepressant). They will receive
an MRI scan at the initial visit and either 6 months after sustained remission or 12 months
after they enter the study for non-remitters. They will also be asked to give a blood sample
for genotyping. They will be matched by age and handedness to healthy volunteers with no
personal history of depression who will also receive an MRI scan and genotyping.
The first aim is to compare hippocampal volume of depressed subjects to healthy controls. It
is anticipated that subjects will initially have smaller hippocampal volume but of those who
sustain remission, there will be a small increase in hippocampal volume. It is also
anticipated that specific genetic markers will be related to individuals response to
antidepressant treatments.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Tofranil-PM has an overall score of 9. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Tofranil-PM review by 31 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | panic attacks |
| Dosage & duration: | | 25mg taken 1 daily for the period of 3 years |
| Other conditions: | | tachycardia |
| Other drugs taken: | | propranolol | | |
Reported Results |
| Benefits: | | After 2-3 weeks complete abatement of panic attack symptoms. After one year tried to stop taking them but within 3 weeks symptoms were back. continued for two more years and stopped taking them. Have not had any symptoms for @10 years now |
| Side effects: | | hyperactivity for up to 8 hrs after taking. |
| Comments: | | started at 5 mg then increased every 5-7 days up to 25 mg. Hyperactivity decreased with longer treatment |
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Page last updated: 2009-11-19
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