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 clomipramine 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. Clomipramine hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) ( see WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use).
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ANAFRANIL SUMMARY
Anafranil®Clomipramine Hydrochloride Capsules USP
(25 mg, 50 mg, and 75 mg)
Anafranil®, (clomipramine hydrochloride capsules USP), is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Anafranil is available as capsules of 25, 50, and 75 mg for oral administration.
Anafranil is 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 Anafranil 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 CMI 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. CMI-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 Anafranil 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 Anafranil 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 Anafranil (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 Anafranil (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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Anafranil has an overall score of 6.50. The effectiveness score is 10 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
| | Anafranil review by 32 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Excessive fears |
| Dosage & duration: | | 50mg taken once a day for the period of 2 years |
| Other conditions: | | None |
| Other drugs taken: | | First 6 weeks combined with oxazepam, later Seroxat | | |
Reported Results |
| Benefits: | | I could function normally again, after 6 weeks sick leave, I had a kind of a Burn-out. |
| Side effects: | | In the first 2-3 month very dry mouth and heavy perspiration. These side effects disappeared after about 3 month. |
| Comments: | | Started with anafranil 50mg once a day combined with oxazepam 10mg three times a day. Anafranil could make the fears worse the first to weeks they told me therefore I had to use oxazepam for 6 weeks. The first four weeks oxazepam 3 times a day 10mg, after that for 2 weeks I used oxazepam 10mg once a day. I have a medical profession and I knew the risks of oxazepam and wanted to stop with it as soon as possible. The first period I had a lot of side effects, dry mouth, have perspiration but it normalised after about 3 month. The first 3 months fear changed in almost fearless but this also normalised after 3 months. The rest of the time I used anafranil I had no side effects. I felt fine, however after 1 year I had to change physician because I moved. The new physician described Seroxat as he thought there was not only a fear issue but also a mild depression. I used Seroxat 20mg once a day for several weeks but did not feel oké. I felt almost without any emotion. Not happy, not sad, nothing. I did not like that at all, I felt worse!! I went back to my physician and we came to a compromise. Once a day 10mg seroxat and once a day Anafranil 25mg. I used this combination for 6 months and I felt good. After 6 month I stopped the Seroxat and used the anafranil 25mg once a day for another 6 months.
I had also psychotherapy as well during these last 6 months. After that I felt oké and stopped without any problems. I feel great now. |
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| | Anafranil review by 25 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | OCD |
| Dosage & duration: | | 250 mg taken daily for the period of 5 years |
| Other conditions: | | Depression |
| Other drugs taken: | | Various. | | |
Reported Results |
| Benefits: | | Over time, this drug caused a massive reduction in my OCD hand washing rituals. I also no longer had to avoid public places for fear of germs. Furthermore, clomipramine caused an immediate decrease in day to day anxiety and worry. |
| Side effects: | | Inability to reach orgasm or ejaculate. Dry mouth. |
| Comments: | | I suffered severe depression and OCD. Clomipramine was not the first drug tried, but it was the only SSRI to work for me. However, any benefits to SSRI drugs are countered by the havoc they play on your sex life. |
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Page last updated: 2009-10-20
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