DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Anafranil (Clomipramine Hydrochloride) - Summary

 
 



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).

 

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).


See all Anafranil indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Anafranil (Clomipramine)

A double-blind, randomized, controlled trial of fluoxetine plus quetiapine or clomipramine versus fluoxetine plus placebo for obsessive-compulsive disorder. [2011.12]
Obsessive-compulsive disorder patients who do not improve sufficiently after treatment with a selective serotonin reuptake inhibitor might improve further if other drugs were added to the treatment regimen... However, the period of monotherapy with the maximum dose of fluoxetine should be extended before a combination treatment strategy is applied.

Effect of aripiprazole augmentation of serotonin reuptake inhibitors or clomipramine in treatment-resistant obsessive-compulsive disorder: a double-blind, placebo-controlled study. [2011.04]
Based on the evidence that aripiprazole added to serotonin reuptake inhibitors (SRIs) or clomipramine in treatment-resistant obsessive-compulsive disorder (OCD) has reported promising results, the present 16-week, double-blind, randomized, placebo-controlled trial had the aim to explore the efficacy of aripiprazole add-on pharmacotherapy on clinical symptoms and cognitive functioning in a sample of treatment-resistant OCD patients receiving SRIs...

Quetiapine versus clomipramine in the augmentation of selective serotonin reuptake inhibitors for the treatment of obsessive-compulsive disorder: a randomized, open-label trial. [2010.03]
After 12 weeks of selective serotonin reuptake inhibitor (SSRI) monotherapy with inadequate response, 10 patients received clomipramine and 11 received quetiapine as augmentation agents of the SSRI. The primary outcome measure was the difference between initial and final scores of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), rated in a blinded fashion, and the score of clinical global improvement (CGI-I)...

The clinical effect of clomipramine in chronic idiopathic pain disorder revisited using the Spielberger State Anxiety Symptom Scale (SSASS) as outcome scale. [2009.12]
BACKGROUND: We have re-analysed our previous double-blind, placebo-controlled clomipramine study, changing the focus from depression to anxiety both in the response analysis and in the classification of minor affective states... CONCLUSIONS: In patients with chronic non-malignant pain, clomipramine is superior to placebo as regards anxiolytic effect measured by Spielberger State Anxiety Symptom Scale (SSASS). No pure analgesic effect was demonstrated.

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.

more studies >>

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.

Predicting Medication Response in Obsessive Compulsive Disorder [Recruiting]
In this study, the investigators hope to study a number of variables the investigators believe may help us predict why some people respond better to some medications than others. Participants will be randomly assigned to receive one of two typical medications for OCD, clomipramine or escitalopram. Individuals who would like to participate but who have previously tried one or both of these medications may instead take a newer drug, duloxetine, and undergo the identical procedures. The factors the investigators will be studying include demographics (i. e. age, gender, age of onset of OCD), genetic markers (such as variants in genes involved in breaking down drugs in the liver (cytochrome P450 system), and genes involved in several brain chemical systems, such as serotonin), the dimensions of OCD symptoms (i. e. checking, washing, and hoarding) and cortical inhibition. Cortical inhibition will be measured transcranial magnetic stimulation and is being studied because deficits in this process may be important in the development of OCD. The investigators hypothesize that certain pretreatment clinical characteristics will correlate with poor treatment response including earlier age of onset, longer duration of illness, increased YBOCS severity and presence of significant hoarding symptoms. The investigators expect that increasing degree of deficit in CI pre-treatment will predict poor treatment response, but that increase in CI from pre- to post-treatment will correlate with a positive treatment response. Differences in genetic marker status for cytochrome P450 genes will correlate with tolerability and/or response, as well as differences in genetic marker status in SLC1A1, GRIN2B, 5HT1B and 5HT2A will correlate with response.

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]

more trials >>

Reports of Suspected Anafranil (Clomipramine) Side Effects

Cytolytic Hepatitis (12)Sopor (10)Cholestasis (9)Liver Injury (8)Jaundice (7)Hepatic Failure (7)Condition Aggravated (7)Hepatic Cirrhosis (6)Alcoholic Liver Disease (6)Ascites (6)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Anafranil has an overall score of 7.33. The effectiveness score is 9.33 and the side effect score is 6.67. 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.

 

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.

 

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.

See all Anafranil reviews / ratings >>

Page last updated: 2011-12-09

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012