Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of clomipramine or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be 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. Clomipramine hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See WARNINGS and PRECAUTIONS: Pediatric Use.)
Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.
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CLOMIPRAMINE SUMMARY
CLOMIPRAMINE HYDROCHLORIDE
CAPSULES USP,
25 mg, 50 mg and 75 mg
ClomiPRAMINE hydrochloride is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants.
ClomiPRAMINE hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of ClomiPRAMINE for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies including two 10 week studies in adults and one 8 week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking ClomiPRAMINE experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. ClomiPRAMINE-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of ClomiPRAMINE for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use ClomiPRAMINE for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
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NEWS HIGHLIGHTS
Published Studies Related to Clomipramine
Mid-term effects of serial sleep deprivation therapy implemented in cognitive-behavioral treatment on the neuroendocrine response to clomipramine in patients with major depression. [2009.04]
While data dealing with neurobiological effects of sleep deprivation (SD) are mainly restricted to the acute effects of a single night, only few studies have investigated mid-term effects after repeated SD... In conclusion, our findings suggest that the mid-term effects of serial SD therapy lead to a normalization of serotoninergic dysfunction, although an obvious impact on clinical symptoms was not detected.
Placebo-controlled double-blind clomipramine trial for the treatment of anxiety or fear in beagles during ground transport. [2006.11]
The purpose of this explorative study was, first, to document changes in physiological parameters and behavior observed in dogs following ground transport and, second, to measure the effects on the above variables of a short-term administration of clomipramine, anecdotally already prescribed in private veterinary practice to reduce fear, anxiety, or both...
Pulse-Loaded Intravenous Clomipramine in Treatment-Resistant Obsessive-Compulsive Disorder. [2006.02]
INTRODUCTION:: Small studies have suggested that intravenous clomipramine (CMI) may be more effective and induce faster improvement in obsessive-compulsive disorder than do orally administered serotonin reuptake inhibitors. OBJECTIVE:: To test these hypotheses, we conducted a randomized, double-blind, double-dummy study of pulse-loaded intravenous versus oral CMI, followed by open-label oral CMI for 12 weeks... CONCLUSIONS:: Further investigation of oral pulse-loading regimens in treatment-resistant obsessive-compulsive disorder is warranted.
Study of the efficacy of fluoxetine and clomipramine in the treatment of premature ejaculation after opioid detoxification. [2006.01]
Premature ejaculation is a common symptom that can provoke relapse in formerly opioid-dependent men after detoxification. The purpose of this study was to compare the efficacy of clomipramine and fluoxetine for the treatment of premature ejaculation in formerly opioid-dependent men after detoxification.
Antidepressant effects of different schedules of repetitive transcranial magnetic stimulation vs. clomipramine in patients with major depression: relationship to changes in cortical excitability. [2005.06]
The antidepressant effects of repetitive transcranial magnetic stimulation (rTMS) that have been demonstrated in recent studies could be related to its ability to modulate cortical excitability. Yet, the relationship between stimulus location and frequency and treatment outcome has not been established...
Clinical Trials Related to Clomipramine
Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-Compulsive Disorder Patients [Completed]
The objective of this trial is to compare in an open trial format the efficacy of association
of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete
remission of obsessive compulsive disorder symptoms.
Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment [Recruiting]
This will be a controlled, randomized, double-blind and double-dummy study on the treatment
augmentation strategy for obsessive compulsive disorder (OCD). The investigators will
compare the association of an SSRI (fluoxetine) with quetiapine, Selective serotonin
reuptake inhibitors (SSRI) with clomipramine and SSRI with placebo for 12 weeks.
Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder [Active, not recruiting]
OBJECTIVES:
I. Evaluate the efficacy of intravenous versus oral pulse loading of clomipramine (CMI)
followed by a 12-week course of maintenance therapy in patients with obsessive compulsive
disorder.
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder [Completed]
Efficacy of Antidepressants in Chronic Back Pain [Not yet recruiting]
This 12 week placebo controlled clinical trial tests the individual and combined effects of
an antidepressant medication and cognitive behavioral therapy for chronic back pain.
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Page last updated: 2009-10-20
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