Effect of Osteopathic Manipulative Therapy on Generalized Anxiety Disorder.

CONTEXT: Traditional management options for generalized anxiety disorder (GAD) have produced low remission rates. As a result, the medical community has turned to complementary and alternative medicine for adjunctive treatment. OBJECTIVE: To investigate the efficacy of adjunctive osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) in individuals with GAD. METHODS: This open-label, nonrandomized, black-box study took place at a tertiary care mental health clinic in Toronto, Canada. Adult outpatient participants aged 18 to 65 years with a primary diagnosis of moderate-severe GAD (HAM-A score of ≥20) with or without comorbidities were enrolled in the study between June 2014 and January 2015. Patients who qualified and completed the study received 5 individually tailored OMTh sessions over the course of 8 to 9 weeks. A diagnostic psychiatric assessment (Mini International Neuropsychiatric Interview version 6.0.0) was conducted to confirm diagnoses, along with physician-administered and self-reported measures of anxiety, including the Hamilton Anxiety Scale (HAM-A), the Beck Anxiety Inventory, and the Intolerance for Uncertainty Scale. RESULTS: Significant reductions in total HAM-A scores after OMTh were observed (P<.0001). Significant reductions in total Intolerance for Uncertainty Scale scores were also observed (P<.0001). Beck Anxiety Inventory scores were not found to change significantly with OMTh. Response (defined as 50% reduction of symptoms) and remission (defined as HAM-A score of ≤7) rates were found to be 62% and 26.9%, respectively. CONCLUSION: Osteopathic manipulative therapy may be a valuable adjunct to conventional therapy in patients with GAD, thus warranting further investigation using double-blind procedures.

Adjunctive Vitamin D in the treatment of non-remitted depression: Lessons from a failed clinical trial.

BACKGROUND: Many patients with depression fail to achieve remission after several consecutive treatments. Vitamin D deficiency is prevalent and new research suggests that it may have an impact on mood, primarily through an effect on neurotransmitters. Numerous observational studies suggest a relationship between low levels of vitamin D and increased incidence and severity of mood disorders. A small number of pilot studies have been undertaken but lack rigorous methodology required to draw conclusions about a clinical role for this nutrient in treatment resistant depression. METHODS: This study was designed as a randomized, double-blind, placebo controlled intervention study administering a weekly (bolus) dose of 28 000IU of Vitamin D3 or placebo to 125 patients with non-remitted depression adjunct to current antidepressant medication. Patients were followed weekly for eight weeks plus a one month follow up. Outcomes measured included depression severity, serum vitamin D levels and safety. Due to slow recruitment during the first season, amendments were made. These included extending the age range to 18-75 and removing the requirement for failing to respond to one pharmacologic antidepressant agent. The protocol was amended to reduce the burden on participants by changing the in-office visits to bi-weekly. Three additional tertiary psychiatric clinics were also added as trial sites. RESULTS: Over three recruitment period years (fall/winter), a total of 148 participants completed screening, 24 (16.2%) of whom qualified to participate in the study. Use of too many or no psychiatric medications, comorbid exclusionary psychiatric conditions, current use of a vitamin D supplement, and lack of participant compensation were the predominant reasons for ineligibility or unwillingness to participate. 9 participants were successfully enrolled in the study, 7 (77.8%) of whom completed the trial as per the protocol. After the third season, futility was declared based on inability to enroll participants. The sample size of enrolled participants (7/125, 5.6%) lacks power to conduct a full assessment of findings. DISCUSSION: High accessibility of vitamin D, as well as a growing lack of equipoise in patients and clinicians about the potential ubiquitous benefits of vitamin D for Canadians, not just for mood disorders, resulted in a large proportion of ineligible potential participants. Limited funding provided to studies on natural health products hampered recruitment. The labile and fluctuating nature of non-remitted depression as well as frequent co-morbid conditions creates additional challenges for conducting trials in this population. Future studies assessing vitamin D in depression should consider our experiences in design and conduct of research. Innovations in clinical trial design such as preference trials or accepting patients already using vitamin D but not achieving an optimal target value are potential solutions to some of these challenges.

Intolerance of uncertainty, social anxiety, and generalized anxiety: Differences by diagnosis and symptoms.

Research suggests that Intolerance of Uncertainty (IU) is related to the severity of suffering in Generalized Anxiety Disorder (GAD). However, its role in Social Anxiety Disorder (SAD) has not been extensively studied. This study examines IU in a clinical sample of 248 individuals referred to a tertiary care clinic. Few individuals had a diagnosis of pure SAD or pure GAD, but we examined differences of IU scores by diagnostic category. We further examined the relationships between IU scores, social anxiety scores, and worry through a structural equation model. We found that diagnostic category (SAD versus GAD) accounted for little variability in IU scores, but IU scores were strongly related to symptoms of both GAD and SAD. Results highlight that IU is related to both social anxiety and worry; however aspects of IU associated with being unable to act or avoiding uncertainty are more strongly associated with SAD symptoms, whereas aspects of IU more associated with general stress and perceiving uncertainty as unfair are more strongly associated with GAD symptoms. Our results suggest that IU is an important concept for both social anxiety and generalized anxiety, however the relationship between IU and symptoms of these disorders manifests differently.

Targeting the Endocannabinoid System in Psychiatric Illness.

Prevalence of psychiatric disorders continues to rise globally, yet remission rates and patient outcome remain less than ideal. As a result, novel treatment approaches for these disorders are necessary to decrease societal economic burden, as well as increase individual functioning. The recent discovery of the endocannabinoid system has provided an outlet for further research into its role in psychiatric disorders, because efficacy of targeted treatments have been demonstrated in medical illnesses, including cancers, neuropathic pain, and multiple sclerosis. The present review will investigate the role of the endocannabinoid system in psychiatric disorders, specifically schizophrenia, depressive, anxiety, and posttraumatic stress disorders, as well as attention-deficit hyperactivity disorder. Controversy remains in prescribing medicinal cannabinoid treatments due to the fear of adverse effects. However, one must consider all potential limitations when determining the safety and tolerability of cannabinoid products, specifically cannabinoid content (ie, Δ-tetrahydrocannabinol vs cannabidiol) as well as study design. The potential efficacy of cannabinoid treatments in the psychiatric population is an emerging topic of interest that provides potential value going forward in medicine.

A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA(®)) and generic novo-methylphenidate ER-C (NOVO-generic).

OBJECTIVE: Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with onset during childhood. Multiple aspects of a child's development are hindered, in both home and school settings, with negative impacts on social, emotional, and cognitive functioning. If left untreated, ADHD is commonly associated with poor academic achievement and low occupational status, as well as increased risk of substance abuse and delinquency. The objective of this study was to evaluate adult ADHD subject reported outcomes when switched from a stable dose of CONCERTA(®) to the same dose of generic Novo-methylphenidate ER-C(®). METHODS: Randomized, double-blind, cross-over, phase IV trial consisted of two phases in which participants with a primary diagnosis of ADHD were randomized in a 1:1 ratio to 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C. Following 3 weeks of treatment, participants were crossed-over to receive the other treatment for an additional 3 weeks. Primary efficacy was assessed through the use of the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II). RESULTS: Participants with ADHD treated with CONCERTA were more satisfied in terms of efficacy and side effects compared to those receiving an equivalent dose of generic Novo-Methylphenidate ER-C. All participants chose to continue with CONCERTA treatment at the conclusion of the study. CONCLUSION: Although CONCERTA and generic Novo-Methylphenidate ER-C have been deemed bioequivalent, however the present findings demonstrate clinically and statistically significant differences between generic and branded CONCERTA. Further investigation of these differences is warranted.

Food for thought: understanding the value, variety and usage of management algorithms for major depressive disorder.

By 2020, depression is projected to be among the most important contributors to the global burden of disease. A plethora of data confirms that despite the availability of effective therapies, major depressive disorder continues to exact an enormous toll; this, in part, is due to difficulties reaching complete remission, as well as the specific associated costs of both the disorder's morbidity and mortality. The negative effects of depression include those on patients' occupational functioning, including absenteeism, presenteeism, and reduced opportunities for educational and work success. The use of management algorithms has been shown to improve treatment outcomes in major depressive disorder and may be less costly than "usual care" practices. Nevertheless, many patients with depression remain untreated. As well, even those who are treated often continue to experience suboptimal quality of life. As such, the treatment algorithms in this article may improve outcomes for patients suffering with depression. This paper introduces some of the principal reasons underlying these treatment gaps and examines measures or recommendations that might be changed or strengthened in future practice guidelines to bridge them.

Optimizing the management of depression: primary care experience.

This article is intended to identify some of the most important challenges faced by family physicians when treating MDD and to provide practical solutions. Key issues, reviewed from a primary care view point will include: treating to remission (and not just response), identification of high-risk groups, diagnosis, acute treatment approaches (including pharmacotherapy and the management of related side effects), the use of psychotherapy and somatic therapies, assessment of the adequacy of treatment including the assessment of remission, response measurement, optimal follow-up care throughout the phase of treatment, the key components of patient education and strategies for partial/limited response to the first-line antidepressant (switching, augmentation and combination strategies), how to provide support for improved treatment adherence, and approaches to prevent the recurrence of depressive episodes.

Efficacy of acupuncture treatment of sexual dysfunction secondary to antidepressants.

BACKGROUND: Antidepressants including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs) are known to cause secondary sexual dysfunction with prevalence rates as high as 50%-90%. Emerging research is establishing that acupuncture may be an effective treatment modality for sexual dysfunction including impotence, loss of libido, and an inability to orgasm. OBJECTIVES: The purpose of this study was to examine the potential benefits of acupuncture in the management of sexual dysfunction secondary to SSRIs and SNRIs. SUBJECTS: Practitioners at the START Clinic referred participants experiencing adverse sexual events from their antidepressant medication for acupuncture treatment at the Mood and Anxiety Disorders, a tertiary care mood and anxiety disorder clinic in Toronto. DESIGN: Participants received a Traditional Chinese Medicine assessment and followed an acupuncture protocol for 12 consecutive weeks. The acupuncture points used were Kidney 3, Governing Vessel 4, Urinary Bladder 23, with Heart 7 and Pericardium 6. Participants also completed a questionnaire package on a weekly basis. OUTCOMES MEASURED: The questionnaire package consisted of self-report measures assessing symptoms of depression, anxiety, and various aspects of sexual function. RESULTS: Significant improvement among male participants was noted in all areas of sexual functioning, as well as in both anxiety and depressive symptoms. Female participants reported a significant improvement in libido and lubrication and a nonsignificant trend toward improvement in several other areas of function. CONCLUSIONS: This study suggests a potential role for acupuncture in the treatment of the sexual side-effects of SSRIs and SNRIs as well for a potential benefit of integrating medical and complementary and alternative practitioners.