Drugs Associated with More Suicidal Ideations Are also Associated with More Suicide Attempts

In randomized controlled trials (RCTs), some drugs, including CB1 antagonists for obesity treatment, have been shown to cause increased suicidal ideation. A key question is whether drugs that increase or are associated with increased suicidal ideations are also associated with suicidal behavior, or whether drug-induced suicidal ideations are unlinked epiphenomena that do not presage the more troubling and potentially irrevocable outcome of suicidal behavior. This is difficult to determine in RCTs because of the rarity of suicidal attempts and completions.To determine whether drugs associated with more suicidal ideations are also associated with more suicide attempts in large spontaneous adverse event (AE) report databases.Generalized linear models with negative binomial distribution were fitted to Food and Drug Administration (FDA) Adverse Event (AE) Reporting System (AERS) data from 2004 to 2008. A total of 1,404,470 AEs from 832 drugs were analyzed as a function of reports of suicidal ideations; other non-suicidal adverse reactions; drug class; proportion of reports from males; and average age of subject for which AE was filed. Drug was treated as the unit of analysis, thus the statistical models effectively had 832 observations.Reported suicide attempts and completed suicides per drug.832 drugs, ranging from abacavir to zopiclone, were evaluated. The 832 drugs, as primary suspect drugs in a given adverse event, accounted for over 99.9% of recorded AERS. Suicidal ideations had a significant positive association with suicide attempts (p<.0001) and had an approximately 131-fold stronger magnitude of association than non-suicidal AERs, after adjusting for drug class, gender, and age.In AE reports, drugs that are associated with increased suicidal ideations are also associated with increased suicidal attempts or completions. This association suggests that drug-induced suicidal ideations observed in RCTs plausibly represent harbingers that presage the more serious suicide attempts and completions and should be a cause for concern

The effectiveness of a web-based self-help intervention to reduce suicidal thoughts: A randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Suicide, attempted suicide and suicidal thoughts are major public health problems worldwide. Effective face-to-face treatments are Cognitive Behavioural Therapy (CBT), Dialectical Behavioural Therapy (DBT) and Problem Solving Treatment (PST). However, about two-thirds of persons who die by suicide have not been in contact with mental health care services in the preceding year, and many have never been treated. Furthermore, many patients do not disclose their suicidal thoughts to their care provider. This may be out of shame, due to fear of stigma or due to lack of trust in (mental) health care. Since many suicidal individuals seek information online, the internet provides an opportunity to reach suicidal individuals who would not be contacted otherwise. By providing a self-help intervention online, persons can anonymously learn to gain control over their suicidal thoughts. There is convincing evidence that self-help is effective for a number of mental disorders. In this study the effectiveness for suicidal thoughts is examined.</p> <p>Methods/Design</p> <p>In this study, a recently developed self-help intervention will be evaluated in a Randomized Controlled Trial. The intervention is based on Cognitive Behavioural Therapy and is aimed at subjects who experience mild to moderate suicidal thoughts. This is defined as a score between 1 and 26 on the Beck Scale for Suicidal Ideation (BSS). Higher and lower scores are excluded. In addition, severely depressed subjects are excluded. In total, 260 subjects will be randomly allocated to the intervention-condition (N = 130) or to the information-control condition (N = 130). Self-report questionnaires will be filled out at baseline, 6 weeks after baseline and 18 weeks after baseline. Primary outcome measure is the reduction in frequency and intensity of suicidal thoughts. Secondary outcome measures are the reduction of hopelessness, anxiety and depression, sleeplessness, worry and quality of life measures.</p> <p>Discussion</p> <p>This study is the first to evaluate the effectiveness of a web-based self-help intervention for suicidal thoughts. Several limitations and strengths of the design are discussed.</p> <p>Trial Registration</p> <p>Netherlands Trial Register, NTR1689</p