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Accutane -- Links to Clinical Studies

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#1 LionQueen

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Posted 21 April 2009 - 08:28 PM

This thread is to be used ONLY to post the links to clinical studies on Accutane. It is here as a resource for everyone in the forum.

Linking to sites OTHER than clinical studies is not acceptable.

Please post any questions or discussion topics elsewhere so that this thread does not get unnecessarily cluttered.

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#2 jmiri

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Posted 21 April 2009 - 08:32 PM

http://www.pnas.org/...111.full?ck=nck
Animal Studies

The first scientific evidence of a link between a drug for severe acne and depression was unveiled by Bath University in September 2006, following years of denials by the manufacturer that the prescription medicine could be in any way responsible for suicides.

The research showed that the drug, which had been given to British teenagers for more than two decades, causes depression in mice. Biochemist Dr Sarah Bailey looked at how healthy mice were affected by a six-week course of Roaccutane, which has a similar structure to vitamin A. She found that when given levels of Roaccutane equivalent to those used to treat teenagers, the creatures developed symptoms of depression, stress or despair. For more information, please click here to download the study in .pdf format .
Other work funded by Mr Grant focused on the the effects of a therapeutic dose of Accutane on the adult brains of mice. It was suggested that if Accutane caused depression then Accutane would influence the "embryonic-like" regions of the adult brain. "Embryonic-like" regions of the adult brain refer to regions where the birth of new neurons continues throughout life.


"13-cis-retinoic acid suppresses hippocampal cell division and hippocampal-dependent learning in mice"

"The results demonstrate that the regions of the adult brain where cell proliferation is ongoing are highly sensitive to disruption by a clinical dose of 13-cis-RA."
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#3 jmiri

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Posted 21 April 2009 - 08:37 PM

http://ajp.psychiatr...t/162/5/983.pdf

Human Studies

"In 1999, Mr Grant, whose own son committed suicide on Accutane, donated money to animal and human studies to examine the effects of Accutane on the adult human brain. Dr. Bremner, who looked at the effects of accutane on brain function using brain imaging presented his findings in November 2004. The study was subsequently published in the American Journal of Psychiatry in 2005. The full study can be downloaded here [Bremner 2005]. Briefly, Dr Bremner compared the effect of Accutane on brain function and compared the results to his published findings of the effects of depression on brain function. Brain function was measured before and after four months of treatment with Accutane (13 patients) and antibiotic (15 patients) using PET scans. Isotretinoin (but not antibiotic) treatment was associated with decreased brain metabolism in the orbitofrontal cortex, a brain area known to mediate symptoms of depression. This study suggests that “isotretinoin treatment is associated with changes in brain function”. The study also proved that Accutane must enter the brain and therefore can cause depression, even if it is an acne drug!"
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#4 jmiri

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Posted 21 April 2009 - 08:51 PM

[Moderator Edit: Please link ONLY to clinical studies. Other links will be removed.]

What is Accutane/Roaccutane? How is it related to Vitamin A?

Accutane/Roaccutane is in the class of compounds called retinoids that includes the active form of Vitamin A.

The active ingredient of Accutane/Roaccutane is Isotretinoin, chemically known as 13-cis-retinoic acid which is related to both retinoic acid (cis-13-retinoic acid is an isomer of all-trans-retinoic acid) and retinol (Vitamin A).

Retinoids are a family of natural and synthetic compounds related to Vitamin A.

The majority of the functions of Vitamin A (growth, vision, reproduction, immune response, nervous system devolopment and maturation) are carried out by its metabolite, retinoic acid -.i.e. Vitamin A does not act function directly rather it acts as a precusor for biologically active retinoids.

Retinoids are powerful regulators of epithelial, differentiation and are essential for its maintance.

Click here for more detailed definitions and descriptons of Vitamin A, retinoids, retinal, retinoic acid etc: Retinoids and Vitamin A

Retinoids : http://www.chem.qmul...c/misc/ret.html

Vitamin A : http://lpi.oregonsta...amins/vitaminA/
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#5 jmiri

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Posted 21 April 2009 - 08:56 PM

What is the mechanism of action of Accutane/Roaccutane?

Accutane/Roaccutane acts to inhibit sebaceous gland secretions. The current label warnings for Accutane/Roaccutane state that "the exact mechanism of action of isotretinoin is unknown".

"Retinoic acid (active form of Accutane/Roaccutane) induces differentiation and reduces proliferation of stem and progenitor cells. It works on acne by inducing similar events in basel sebocytes. These same actions also lead to 13-cis-retinoic's side effects, and these are directed towards proliferating cells in the adult such as in the skin, gut and bone." Crandall 2004

"A wide ranging effect of retinoic acid is to inhibit proliferation in dividing cells, and this accounts for its frequent consideration as an anti-cancer agent."Crandall 2004.

http://www.pnas.org/...111.full?ck=nck


http://www.accutanea.../2005_Barak.pdf
describes five adults (5/500 soliders) who devoloped manic psychosis...The present case-series is suggestive of an increase in the likelihood of an association between exposure to isotretinion and manic psychosis.

Affective Psychosis following Accutane (isotretinoin) treatment. Int Clin Psychopharmacology. Barak Y.2005. Isotretinoin (Accutane) ranks in the top 10 of the US Food and Drug Administration's database of drugs associated with reports of depression and suicide attempts. However, this association is still controversial because up to 5.6% of patients with moderate acne may have pre-existing suicidal ideations, improvement of acne often reduces associated depression, and isotretinoin users are reportedly no more likely than those taking antibiotics for acne to have depression or commit suicide. We describe a series of cases of manic psychosis that developed in a 1-year period (2003) in association with isotretinoin treatment and resulted in suicidality and progression to long-standing psychosis. Cases were drawn from 500 soldiers who had been evaluated in a military specialists dermatology clinic for severe acne. Data were summarized from medical records of five severe acne patients treated by isotretinion during their compulsory military service. Data from their draft board examinations and service records, as well as repeated clinical assessments by certified psychiatrists at the Israel Defense Forces (IDF) Mental Health Department clinic, were evaluated. Five young adults developed manic psychosis within a mean of 7.6 months of exposure to isotretinoin. In three cases, this was accompanied by a suicide attempt, and in three cases, psychosis lasted for longer than 6 months. Either a personal history of obsessive-compulsive disorder, neurological insult or family history of a major psychiatric illness were present in all cases. The present case-series is suggestive of an increase in the likelihood of an association between exposure to isotretinion and manic psychosis. Associated risk factors were both family and personal history of psychiatric morbidity. Further studies are needed to establish our findings.
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#6 maddy001

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Posted 22 April 2009 - 04:29 AM

www.jpad.org.pk/july-sep%202005/adverse%20effects%20isotretinoin.pdf
http://www.pubmedcen...;tool=pmcentrez
http://www.pubmedcen...;tool=pmcentrez
http://www.pubmedcen...;tool=pmcentrez

I posted those that are more recent because I think they are more reliable.

The first 2 are on population studies while the other 2 are on the relation of accutane to depression.

I hope it helps.
Accutane done. Started 01/06/2007 Ended 24/01/2008

My accutane log

天若无雨 地上无伞
思念西湖边 杨柳飞雪堆烟
茫茫人海 心无岸
修炼一千年 一万年也无怨
心若不安 痛能看见
泪淹没视线 化火焰烧红天
剪不断 理还乱前缘



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#7 jmiri

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Posted 25 April 2009 - 03:12 PM

http://www.bath.ac.u...eserotonin.html

"Research suggests mechanism for acne drug’s link to depression

New research has found that a drug used to treat severe forms of acne reduces the availability of the chemical serotonin, low levels of which have been linked to aggression and clinical depression.

In a study published in the journal Experimental Biology and Medicine, scientists reveal a potential mechanism that might link the drug Roaccutane (Accutane in the US) to reported cases of depression in some patients taking the medication.

The researchers had previously reported that the drug caused depressive behaviour in mice but, until now, the mechanism by which this might happen was unknown.

Using cells cultured in a laboratory, scientists from the University of Bath (UK) and University of Texas at Austin (USA) were able to monitor the effect of the drug on the chemistry of the cells that produce serotonin.

They found that the cells significantly increased production of proteins and cell metabolites that are known to reduce the availability of serotonin.

This, says scientists, could disrupt the process by which serotonin relays signals between neurons in the brain and may be the cause of depression-related behaviour."

“Serotonin is an important chemical that relays signals from nerve cells to other cells in the body,” said Dr Sarah Bailey from the Department of Pharmacy & Pharmacology at the University of Bath.

“In the brain it is thought to play an important role in the regulation of a range of behaviours, such as aggression, anger and sleep.

“Low levels of serotonin have been linked to depression, as well as bipolar and anxiety disorders.

“Many medications aimed at treating depression seek to increase levels of serotonin to help overcome these problems.

“Our findings suggest that Roaccutane might disrupt the way serotonin is produced and made available to the cells.

“This could result in problems associated with low levels of serotonin, which might include depression.

“We are currently looking into this mechanism in more detail.”

The research is funded by the National Institute of Environmental Health Sciences, the National Institutes of Health and the University of Texas at Austin.
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#8 acnewhat?

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Posted 10 May 2009 - 08:56 PM

http://www.medscape....warticle/533745

"Investigators in Israel conducted a prospective, observational, open-label study of isotretinoin in 638 patients with moderate acne. Patients were divided into two groups. Group 1 contained 495 patients aged 12 to 20 years with a 2:1 female:male ratio. Group 2 contained 122 patients aged 21 to 35 years with a 3.5:1 female:male ratio. All patients received 20 mg/day of isotretinoin for 6 months. Patients were evaluated every 2 months through unblinded clinical examinations and laboratory tests. Pregnancy tests were done at baseline for women with childbearing potential. Follow-up was not explicitly reported but took place over a period of up to 4 years.

A total of 617 patients completed the study. In group 1, 95% of patients achieved considerable improvement or complete remission of their acne; 26 patients (5%) did not respond and either their isotretinoin dose was increased to 30–40 mg/day, oral erythromycin was added, or the low-dose isotretinoin was continued for 8 months until remission occurred. The mean cumulative dose in group 1 was 70 mg/kg. In the follow-up period, 20 patients (4%) relapsed. Polycystic ovary syndrome was subsequently diagnosed in 7 of the patients who relapsed.

In group 2, 93% achieved significant improvement or remission, and 7% did not respond. In these nonresponders, the isotretinoin dose was either increased or continued at the low-dose level for 9 months until remission was achieved. The mean total dose was 67 mg/kg. Seven patients (6%) relapsed; of these, polycystic ovary syndrome was diagnosed in two."

to summarize, researchers wonder why there isn't much info on low dose accutane so a bunch of them in Israel conducted an experiment with over 600 people with moderate and low dose accutane (20mg a day) and in 6 months almost all of them were clear. checking 4 years later only 5-7% of them ever relapsed. The total cumulative dose ended up being 67-70mg while in current accutane courses dermatologists and even Roche themselves aim for 125ish. Also shows minor side effects occured.

#9 beachkrazd

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Posted 01 June 2009 - 05:33 PM

'A Population-Based Analysis of Laboratory Abnormalities During Isotretinoin Therapy for Acne Vulgaris'

http://archderm.ama-...rint/142/8/1016
Archives of Dermatology, Vol 142, AUG 2006

(Archives of Dermatology is a monthly professional medical journal published by the American Medical Association.)

#10 biggs881

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Posted 22 March 2011 - 07:55 PM

What is the incidence of severe side effects while on Accutane?

http://www.ncbi.nlm....pubmed/21198520

Basically, the study investigated the incidence of side effects - severe and non-severe - in 1743 people who underwent a standard course of Accutane (isotretinoin), with 703 of the 1743 people receiving a high dose of 0.76-1.0 mg/kg/day.

In the 1743 people studied, which included 703 who took a high daily dose, the only serious adverse events prompting treatment discontinuation were 2 pregnancies (~0.1%). While Accutane is a known teratogen, it does not cause pregnancies.

TABLE.JPG

Furthermore, 93.2% of the 1743 people were completely cleared by Accutane.
.

Edited by biggs881, 25 April 2011 - 08:05 AM.


#11 Wynne

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Posted 17 April 2011 - 10:26 PM

QUOTE (LionQueen @ Apr 21 2009, 10:28 PM) <{POST_SNAPBACK}>
This thread is to be used ONLY to post the links to clinical studies on Accutane. It is here as a resource for everyone in the forum.

Linking to sites OTHER than clinical studies is not acceptable.

Please post any questions or discussion topics elsewhere so that this thread does not get unnecessarily cluttered.

ABSOLUTELY NO FLAMING WILL BE TOLERATED.

Posts that do not follow these guidelines will be invis'd.

Again, a reminder of this thread's rules.

Take responsibility for your health; read the full prescribing information for any medication you take and understand that not all risks or potential side effects will likely ever be fully known.

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#12 borie88

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Posted 27 October 2011 - 05:58 PM


Isotretinoin Influences Pituitary Hormone Levels in Acne Patients



*Note: Abnormal hormone levels can be linked to the cause of acne.
**This means that accutane can in effect cause acne again, or just cause hormone problems.
***Also note that the study was only 3 months. Many trials last longer, probably further depleting some of the hormones discussed.

Besides suppressing sebum production, the exact mechanism of action of isotretinoin in acne vulgaris is not known. Several hormones have been linked to the pathogenesis of acne. In this study, we investigated the effects of isotretinoin on the pituitary-adrenal axis, whose activity may be increased in acne. Various hormone systems were evaluated before and after 3 months of isotretinoin treatment in 47 acne patients. Free triiodothyronine (T3), thyroid-stimulating hormone and thyroid-stimulating hormone receptor antibody levels decreased significantly during isotretinoin treatment (p < 0.001, p < 0.02 and p < 0.02, respectively), as did those of luteinising hormone, prolactin and total testosterone (p < 0.005), as well as morning cortisol and adrenocorticotropic hormone (p < 0.005 and p < 0.05, respectively). We conclude that isotretinoin causes mild suppression of pituitary hormone levels, which may be beneficial for tackling the pathogenesis of acne.

http://www.medicaljo...555-1013&html=1
-Accutane twice - Worked for a little while, then it all came back. NOT WORTH IT! Read the Accutane research post (Including mine) to see how Accutane can screw up someone's body and even cause acne itself.
-Differin, EpiDuo, BP. Tazorac, BHA, AHA - have used all of these at some point but never been more than 90% clear with any.
-As of Nov. 2010 - Stay away from too many carbs, especially high GI carbs. We were made to eat raw foods, not anything from a box! Eat grassfed meats!
-Trying to heal my gut with L-Glutamine, Zinc, and a lower-fat diet. Also trying iodine/selenium supplementation for thyroid.