S-Adenosylmethionine Compared to Placebo in Improving Depression Symptoms in Adults with Major Depressive Disorder

Twenty to twenty-five percent of adults may suffer an episode of major depression at some point during their lifetime. Antidepressant and/or psychotherapy are the current recommended treatments for depression. The supplement S-Adenosylmethionine (SAMe), a naturally occurring compound that is found in the human body, as a possible method of treatment for depression for those who are resistant to traditional antidepressants or for those who cannot tolerate the side effects of antidepressants. Databases that were utilized for this paper were CINAHL and MEDLINE with the search parameters including SAMe , depression and adults. Purpose – To assess the effectiveness of treatment with S-adenosylmethionine for major depression disorder, measured by the Hamilton Rating Scale for Depression. Methods – Five random double-blind studies using HAM-D scores from inpatient and outpatients receiving SAMe and patients receiving a placebo were compared. Results – Two of the five studies reviewed indicated no significant difference in symptom improvement for patients with depression utilizing the HAM-D tool when comparing the administration of SAMe and the administration of a placebo. There were two studies that did not show a significant difference between groups. Three of the studies did show a significant reduction in HAM-D score between SAMe and placebo groups. The p value for the three studies which showed a reduction in HAM-D scores was less than 0.05. Conclusions – The study designs were strengths in all five studies. Weaknesses included the short term lengths of all studies and small sample sizes. Further studies will be required before recommendations can be included in guidelines pertaining to the use of SAMe for the treatment of depression. There does appear to be a role for SAMe in the treatment of major depression in adults after more studies are conducted. Running Head: NURS 7100 S-Adenosylmethionine Compared to Placebo in Improving Depression Symptoms in Adults with Major Depressive Disorder 3 The importance of this scholarly paper for clinical practice includes patients with depression may have severe side effects from traditional antidepressant therapy or they are resistant to antidepressant therapy. Several natural supplements, such as St. John’s Wort and SAMe, have been investigated and have shown success in improving symptoms of major depressive disorder. Depression is described as a constant sense of hopelessness and despair. Those who have depression have difficulty working, studying, sleeping, eating and enjoying friends and activities. Depression seems to be passed on from one generation to the next, but may affect people with no family history of illness (Web MD, 2012). Almost seven percent of the U.S. population over age 18 suffers from depression. Twenty to twenty five percent of adults may suffer from major depression at some point during their lifetime. Depression may affect older adults, teens and children, but frequently goes undiagnosed and untreated in these populations. Twice as many women than men have been diagnosed with depression. Hormonal changes during puberty, menstruation, pregnancy, miscarriage and menopause may increase the risk for depression. Increased stress at home or at work, balancing life with career, and caring for an aging parent may increase one’s risk for depression. Men are less likely to seek help or talk about their depression. Signs in men may include irritability, anger, or drug and alcohol abuse. Repressive feelings can result in violent behavior directed both inwardly and outwardly. Depression in men can result in an increase in illness, suicide, and homicide (Web MD, 2012). Most elderly feel satisfied with their lives and depression is not a normal part of aging. Many elderly with depression are reluctant to seek help and the depression may go undiagnosed because symptoms may be less obvious and may seem to be caused by other illnesses. (Mayo Clinic, 2012). DSM-IV symptoms for depression include: depressed mood most of the day, particularly in the morning; loss of interest in normal activities and relationships; fatigue or loss of energy Running Head: NURS 7100 S-Adenosylmethionine Compared to Placebo in Improving Depression Symptoms in Adults with Major Depressive Disorder 4 almost every day; feelings of worthlessness or guilt almost every day; impaired concentration and indecisiveness; insomnia or hypersomnia almost every day; markedly diminished interest or pleasure in almost all activities nearly every day; restlessness or feeling slowed down; recurring thoughts of death or suicide and significant weight loss or gain (Web MD, 2012). Common triggers for depression include: grief from losing a loved one through death, divorce, or separation; social isolation or feelings of being deprived; major life changes such as moving, graduation, a job change, or retirement; personal conflicts in relationships, either with significant other or superior; and physical, sexual or emotional abuse (Web MD, 2012). In some cases, depression can present with psychotic symptoms such as hallucinations and delusions (National Library of Medicine, 2011). The purpose of this paper is to compare S-Adenosylmethionine (SAMe) versus placebo in improving symptoms of depression in adults with major depressive disorder. S-Adenosylmethionine, or commonly called SAMe, is a naturally occurring compound that is found in almost every tissue and fluid in the body. It is not found in food and is produced by the body from ATP and the amino acid methionine. SAMe is involved in many body processes including a role in the immune system, to help maintain cell membranes and assist in production and break down of brain chemicals such as serotonin, melatonin and dopamine. SAMe interacts with Vitamin B12 and Folate to enhance these body processes. SAMe works more quickly than standard antidepressants and it is speculated that it increases the amount of serotonin in the brain (University of Maryland Medical Center, 2012). The importance of implications for quality of life for the patient, their family and society are numerous. SAMe could be identified as an alternative to antidepressant monotherapy where it could be a solution for those who are resistant to traditional antidepressant therapy. If SAMe is Running Head: NURS 7100 S-Adenosylmethionine Compared to Placebo in Improving Depression Symptoms in Adults with Major Depressive Disorder 5 found to be effective in a depressed patient, this could improve their quality of life for themselves and their family by becoming more productive in society through work and other activities outside of the home. The patient population studied includes adults, ages eighteen to seventy five, with major depressive disorder. The intervention under study is either SAdenosylmethionine compared with placebo. The intended outcome is improvement in depression symptoms utilizing the HAM-D scoring tool. This study analysis and recommendations are related to the nurse practitioner primary care practice because providers need to be aware of all possible treatments for their patients with major depressive disorder as they choose and individualize the course of treatment for each patient. Analysis Janicak, Lipinski, Davis, Comaty, Waternaux, Cohen, Altman, & Sharma (1988) compared SAMe and placebo in a randomized double-blind study in patients with depression who were hospitalized for two weeks. Seven patients received 400 mg of SAMe a day via intravenous access and three patients received a placebo. The authors found a reduction in HAM-D scores which decreased from 33.6 to 21.2 for the SAMe group and from 32.9 to 30.5 for the placebo group. The p value was less than 0.02 which is a significant finding. This study is considered to be a level one due to the randomized, double-blind study design, the quality ranked at a two, and the strength of this double-blind study is a D as the researchers indicated SAMe should not be administered for depression without specific considerations. The results were significant and the authors suggested that further studies were required before recommending SAMe solely for the treatment of depression. In a six week study by Fava, Rosenbaum, Falk, Pollack, Cohen, Cohen, & Zubenko (1990), thirty nine outpatients with depression were randomized to receive either SAMe 1600 mg a day Running Head: NURS 7100 S-Adenosylmethionine Compared to Placebo in Improving Depression Symptoms in Adults with Major Depressive Disorder 6 orally or a placebo. The authors found there was no significant difference between the SAMe and placebo group with a p value of 0.15. This was a randomized, double-blind study designated to be a level one, the quality is ranked at a two, and the strength is a C since there was poor evidence to support or reject the use of SAMe in the treatment of depression. Sixty outpatients with depression and rheumatoid arthritis were researched by Caruso, Fumagalli, Bosccassini, Puttini, Santandrea, & Ciniselli (1987) in a level one, randomized, double-blind experiment where the patients received either 200 mg of SAMe via intramuscular injection or a placebo. A key feature in this quality two study is that each subject had the diagnosis of rheumatoid arthritis and major depressive disorder. A p value of less than 0.01 was determined by the researchers with HAM-D scores reduced from 45.1 to 33.1 in the SAMe group and from 42.4 to 39.7 for the placebo group. The authors concluded that more studies were required for SAMe to be implemented into routine practice for the treatment of depression in patients who also have the co-morbidity diagnosis of rheumatoid arthritis. This designates the strength of this study at a D since SAMe should not be recommended for treatment of depression at this time. In a randomized, double-blind study by Agnoli, Andreaoli, Casacchia, & Cerbo (1976), thirty patients with depression were hospitalized for twenty two days. The patient age