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Das Helmholtz Forum Forschungssoftware, welches gemeinsam von der Task Group Forschungssoftware des AK Open Science und dem HIFIS Software Cluster getragen wird, veranstaltete am 7. April 2022 ein Helmholtz Open Science Forum zum Thema Forschungssoftware. Die Veranstaltung wurde vom Helmholtz Open Science Office organisiert. Das virtuelle Forum widmete sich drei Aspekten beim offenen und nachhaltigen Umgang mit Forschungssoftware in der Helmholtz-Gemeinschaft: Policy, Praxis sowie Infrastrukturen und Tools. Die Veranstaltung war die zweite einer Reihe von Helmholtz Open Science Foren zum Thema. Die erste Veranstaltung fand im Mai 2021 unter dem Titel „Policies für Forschungssoftware“ statt. Vorliegender Bericht dokumentiert die Veranstaltung.

In this article, we provide information on patient-reported side effects from a cross-section of real-world patients. Specifically, data on side effects were tabulated for patients taking at least one of the following atypical antipsychotic medications: aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, or ziprasidone. Approximately 54 percent of the 353 respondents reported having experienced a side effect as a result of taking an atypical antipsychotic medication. Most common side effects mentioned included the following: weight gain/hunger, tiredness/lethargy, and lack of coordination/muscle problems, such as tenderness, twitches, and tremors. Of those experiencing a side effect, less than 25 percent reported this side effect to their physician.

In this article, we provide information on patient-reported side effects from a cross-section of real-world patients. Specifically, data on side effects were tabulated for patients taking one of the following attention deficit hyperactivity disorder medications: amphetamine and dextroamphetamine; atomoxetine; dexmethylphenidate; isdexamfetamine; and methylphenidate. Forty-eight percent of the approximately 325 patients surveyed reported having experienced a side effect as a result of taking an attention deficit hyperactivity disorder medication. Most common side effects mentioned included loss of appetite, sleep problems, and mood disturbances. Only 21 percent of side effects were considered very bothersome or extremely bothersome. Regardless of how bothersome the side effects were, only 20 percent of patients mentioned the side effects to their prescribing physicians.

In this article, we explore the penetration of generic atypical antipsychotics in the United States market before and after the availability of generic risperidone in July 2008. Analysis suggests that, overall, generic penetration into the atypical antipsychotic market has grown from approximately three percent in January 2008 to more than 25 percent in December 2009. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

We analyzed the trends in product regimens used to treat depression to investigate whether there has been a shift in treatment patterns following the May 2008 launch of desvenalfaxine in the United States and the approval of an atypical antipsychotic as add-on therapy to antidepressants. Our analysis suggests that antidepressant monotherapy continues to be the most widely used drug treatment approach, accounting for 84 percent of depression treatment regimens. Antidepressant monotherapy is more prevalent among primary care physician-prescribed treatment regimens (92%) than psychiatry-prescribed regimens (73%). Combination treatment regimens have become increasingly more common as physician perception of disease severity increases, with antidepressant combination therapy accounting for eight percent, 17 percent, and 27 percent of treatment regimens for mild, moderate, and severe depression, respectively. The most commonly used agents in addition to an antidepressant in combination treatment regimens include another antidepressant (40% of combination regimens), an anxiety agent (40%), and/or atypical antipsychotics (18%). A trend analysis suggests that combination regimens that include an antidepressant plus an atypical antipsychotic, anxiety agent, or a prescription sleep aid comprise a greater share of combination regimens in 12 months ending May 2009 than they did in 12 months ending June 2008.

In this article, we investigate the range of treatments prescribed for schizoaffective disorder. The data show that the majority of those treated, 87 percent, receive two or more pharmaceutical classes. From a therapeutic class perspective, 93 percent of schizoaffective disorder patients receive an antipsychotic, 48 percent receive a mood disorder treatment, and 42 percent receive an antidepressant. An expert commentary is also included.

In this article, we provide information on patient-reported side effects from a cross-section of real-world patients. Specifically, data on side effects was tabulated for patients taking one of the following selective serotonin reuptake inhibitor antidepressants: citalopram, escitalopram, fluoxetine, paroxetine, and sertraline. Thirty-eight percent of the approximately 700 patients surveyed reported having experienced a side effect as a result of taking a selective serotonin reuptake inhibitor antidepressant; the most common side effects mentioned were sexual functioning, sleepiness, and weight gain. Only 25 percent of the side effects were considered "very bothersome" or "extremely bothersome." Regardless of how bothersome the side effects were, however, only 40 percent of patients mentioned the side effects to their prescribing physicians.

Because of limitations in diagnosis coding, it is difficult to determine which products are used to treat premenstrual dysphoric disorder. To better understand treatment of premenstrual dysphoric disorder, we examined the antidepressant prescribing behavior of obstetrician/gynecologists as a marker for premenstrual dysphoric disorder treatment and compare these use patterns to psychiatrists and primary care physicians. Over the past quarter, only three percent of antidepressants were prescribed by obstetrician/gynecologists as compared to 51 percent by primary care physicians and 20 percent by psychiatrists. Obstetrician/ gynecologists more frequently use selective serotonin reuptake inhibitors (69% compared to 58% in primary care and 48% in psychiatry) and are more likely to choose an selective serotonin reuptake inhibitors agent indicated for the treatment of premenstrual dysphoric disorder (e.g., fluoxetine, paroxetine, sertraline): 66 percent versus 59 percent for both primary care physicians and psychiatrists. Use of desvenlafaxine was slightly elevated in obstetrician/ gynecologists as compared to primary care physicians (0.3% vs. 0.1% of total antidepressants, respectively); however, psychiatrists prescribed more desvenlafaxine than either group: 0.4 percent of total antidepressant prescriptions. Discussion of this data is provided.

Primary care physicians, pediatricians, and psychiatrists account for approximately 80 percent of attention deficit hyperactivity disorder (ADHD) treatments prescribed in the United States. Selection of short-acting versus long-acting ADHD treatment varies by specialty with long-acting agents representing 56 percent of primary care prescriptions, 64 percent of psychiatrist prescriptions, and 79 percent of pediatric prescriptions. There appears to be a correlation between short-acting versus long-acting treatment selection and age, with long-acting agents accounting for 78 percent of prescriptions for pediatric patients (age 0-17) but only 49 percent of prescriptions for adults (patients aged 18+). A discussion of data is included.

To evaluate the safety and efficacy of carbamazepine extended-release capsules (CBZ-ERC) in combination with other psychotropic medications for the treatment of bipolar I disorder.In this Phase IIIb, open-label, eight-week, observational, polypharmacy study, adult subjects were started on CBZ-ERC 200mg and titrated over four weeks to optimal dose (1600mg/d maximum). Concomitant lithium and atypical antipsychotics (olanzapine, risperidone, quetiapine, aripiprazole) were permitted. Safety assessments included adverse events, laboratory parameters, physical examination, medication history, vital signs, and electrocardiogram. Efficacy measures included the Young Mania Rating Scale (YMRS), Hamilton Rating Scale for Depression (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), and Clinical Global Impressions Scale-Bipolar Version (CGI-BP). All data were summarized using descriptive statistics.Overall, 45 (84.9%) subjects reported treatment-emergent adverse events (TEAEs); most were mild or moderate in severity. The most commonly reported TEAEs were somnolence (n=14, 26.4%), sedation (n=12, 22.6%), dizziness (n=11, 20.8%), headache (n=9, 17.0%), and nausea (n=7, 13.2%). There were no clinically significant changes in vital signs, including weight. Mean changes in laboratory parameters were small, with values that were within the normal range for the majority of subjects. Few changes relative to screening for other safety parameters occurred. Mean total YMRS score decreased from baseline at each study visit. HAM-D and MADRS scores decreased from baseline at Weeks 4 and 8, and all three CGI-BP components (overall bipolar disorder, mania, and depression) improved during the study.CBZ-ERC appears to be safe and effective for use in combination with atypical antipsychotics and lithium for treatment of bipolar I disorder.

We investigated the current practice for treatment of schizophrenia. According to our data, 47 percent of patients with schizophrenia are treated with only antipsychotic medication. An additional 43 percent of patients receive one additional class to supplement their antipsychotic medication, and 10 percent of patients are prescribed two or more classes of drugs in addition to an antipsychotic medication. The most common classes used to supplement antipsychotic medications in the management of schizophrenia include antidepressants (28%), mood stabilizers (18%), agents to treat extrapyramidal symptoms (7%), and sleep aids (5%).

We investigated the use of antidepressants in the treatment of depression. According to our data, antidepressants are most commonly used alone (85%); however, the prevalence of antidepressant monotherapy decreases as the physician's impression of patient severity increases (92% mild, 84% moderate, 73% severe). Psychiatrists are more likely to use antidepressant combinations than primary care physicians (32% vs. 8%). With respect to combination therapy, the most likely agent to be used in combination with an antidepressant in the treatment of depression was another antidepressant (6.4%); followed by anxiety agents (5.2%), antipsychotics (2.4%), and mood stabilizers and sleep aids (1.2% each). An expert commentary on the data is provided.

We investigated the share of branded and generic antipsychotics before and after the publication of the CATIE results in September, 2005. According to our data, the publication of the CATIE results has had very little impact on new patient starts. To determine the impact of CATIE on use of olanzapine (Zyprexa((R))) subsequent to first line therapy, we also examined product share for switch/add patients. We found that since the publication of the CATIE results, the use of olanzapine has stabilized, following a decline subsequent to first line therapy, and may potentially be growing very slowly. An expert commentary is provided on the data.