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 (
WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients,
PRECAUTIONS: Pediatric Use
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.
Media Articles Related to Tofranil-PM (Imipramine)
Trial review confirms common antidepressant is 'unsafe and ineffective' for teens
Source: Litigation / Medical Malpractice News From Medical News Today [2015.09.17]
From a reanalysis of original trial data from 2001, researchers find the antidepressant paroxetine and the higher dosage drug imipramine are no better than a placebo.
Postpartum depression least severe form of depression in mothers
Source: Depression News From Medical News Today [2016.06.17]
Time frame when pregnant woman first develops depression determines severity, treatment of it.
Untreated Depression in Pregnancy Linked to Low Birth Weight
Source: Medscape Psychiatry & Mental Health Headlines [2016.06.16]
A new analysis also found increased risk for preterm births among expectant mothers with untreated depression.
Medscape Medical News
Community-based programme improves depression in chronic pain patients
Source: Depression News From Medical News Today [2016.06.15]
A community-based pain management programme for patients with chronic musculoskeletal pain has improved depression and social integration, according to a study led by Queen Mary University of...
Major depression: Most antidepressants ineffective for children, teens
Source: Depression News From Medical News Today [2016.06.09]
A review in The Lancet finds that most antidepressants offer no benefit for children and adolescents with major depression, and they may even cause harm.
Published Studies Related to Tofranil-PM (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
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-PM (Imipramine)
Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions [Completed]
The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg
Capsules under fasting conditions
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.
To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions [Completed]
Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome [Active, not 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.
Dichotic Listening as a Predictor of Medication Response in Depression [Completed]
Depressed patients will have hearing tests and then be treated with up to three treatments
(i. e., Fluoxetine, Imipramine and Placebo) until remitted, to see whether test results
predict specific outcomes.
PATIENT REVIEWS / RATINGS / COMMENTS
Based 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
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || panic attacks|
|Dosage & duration:|| || 25mg taken 1 daily for the period of 3 years|
|Other conditions:|| || tachycardia|
|Other drugs taken:|| || propranolol|
|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|
Page last updated: 2016-06-17