October 28, 2018 by Sandra Steingard, MD | Community Mental Health Journal
Five Year Outcomes of Tapering Antipsychotic Drug Doses in a Community Mental Health Center
There is evidence that many individuals are on higher doses of antipsychotic drug than is required for optimal functioning yet there are limited guidelines on how to reduce them. This paper reports on 5 year outcomes for sixty-seven individuals who received treatment at a community mental health center and were offered the opportunity to gradually reduce their doses of antipsychotic drug in collaboration with the treating psychiatrist. Over a period of 6 months, the author invited patients who were clinically stable and able to participate in discussions of potential risks and benefits to begin gradual dose reductions. Initially, 40 expressed interest in tapering and 27 declined. The groups did not differ in age, sex, race, or diagnosis. The group who chose to taper began on significantly lower doses. Most patients succeeded at making modest dose reductions. At 5 years, there were no significant differences in the two outcomes measures, rate of hospitalization and employment status. Many patients were able to engage in these discussions which did not result in widespread discontinuation of drug. This is a naturalistic, small study of a topic that warrants further research.
Antipsychotic drugs are considered first-line treatment for psychosis (Association 2006). Standard guidelines recommend that they are started as soon as possible after the emergence of symptoms (Association 2006). It is also recommended that they are continued indefinitely to reduce the risk of reemergence of psychosis (Association 2006). In recent years, questions have been raised about this paradigm of care. There are individuals who may recover without medications (Harding et al. 1987). Data suggest that long-term use of these drugs may impair functional outcome (Harrow et al. 2017; Wunderink et al. 2013). However, the suggestion that antipsychotic drugs may worsen long-term outcomes is controversial and needs to be considered against the considerable body of data showing a significantly higher rate of relapse to psychosis when the drugs are stopped (Leucht et al. 2012). A recent expert consensus panel concluded that the data on risks of functional impairment and brain atrophy remain inconclusive and that the clear increased risk of relapse when drugs are stopped still favors long-term use of these drugs (Goff et al. 2017).
However, there are other reasons to consider dose reduction. These drugs are associated with significant morbidity including increased risk of weight gain, metabolic syndrome (Pramyothin 2010), and tardive dyskinesia (Lerner et al. 2015). In the context of the already high morbidity among patients who are most often prescribed these drugs (Olfson et al. 2015), insuring that patients are prescribed the minimally effective dose is warranted. However, even early in the course of care, it appears that patients are often on more drug than is necessary. Patients may be stabilized on a dose of antipsychotic during an acute crisis that may not be necessary for long-term care. For instance, in the RAISEETP study of individuals experiencing a first episode of psychosis, at entry into the study 23.3% were on more drug than recommended (Robinson et al. 2015). Expert consensus panels have suggested that the dose required for acute stabilization of symptoms may be greater than what is required for long-term relapse prevention (Association 2005).
Thus, there may be many patients who are on a higher dose of antipsychotic drug than is needed to reduce risk of relapse. Yet the identification of optimal doses for long-term treatment can be challenging.
There is, thus, both an important gap in our current knowledge regarding antipsychotic drug taper as well as differences of opinion about whether it is advisable to suggest a dose taper in patients who are clinically stable. This paper presents data from the clinical practice of a psychiatrist (the author) who concluded that informed consent warranted a discussion of not only the generally accepted risks of long-term exposure to these drugs vs. risks of taper but also the possible negative impact of the drugs on long-term functional outcome. The patients under study were invited by their treating psychiatrist to consider a taper of their neuroleptic drug doses. Patients were tracked over 5 years and, through chart review, their outcomes were assessed.
The patients were all enrolled in the Community Support Program at the Howard Center, Burlington Vermont. This program, supported by the state’s Department of Mental Health, has eligibility requirements which include having had evidence of impairment in functioning as well either failure to improve in standard outpatient treatment or having multiple hospitalizations in the year prior to enrollment.
Since patients are continually enrolled and discharged from this program, there is a constant flux in census but the range over this time was 600–650 clients. The most common diagnoses of clients in this program are schizophrenia spectrum disorders but there are also patients who have mood disorders or borderline personality disorder. Clients receive psychiatric care, case management, and a wide variety of community supports including supported housing and employment.
Population Studied and Inclusion Criteria
The patients included in this report were all patients of the author. Over a period of 6 months, she tracked all patients she saw in this clinic who met the following criteria: they had been treated in the clinic for at least a year during which time they had been prescribed an antipsychotic drug at a stable dose. They had not had any hospitalizations in the past year. In the judgement of their psychiatrist, they were judged to be clinically stable (although not necessarily without psychotic symptoms) and able to engage in a discussion about the risks and benefits of trying to slowly taper their dose of antipsychotic drug. They needed to demonstrate that they understood that by reducing their dose they were at a higher risk of recurrence or worsening of their psychotic symptoms. They also discussed the emerging evidence that the drugs might impair their functional outcome (described as returning to work, having meaningful relationships) and it was explained that these ideas were controversial and that there were psychiatrists who would not recommend drug taper in these circumstances. When family was available, they were invited into the discussion although this was not done in a systematic way. These discussions and decisions were reviewed at subsequent visits. Visit frequency varied and was determined by clinical need. They tended to range between every 1 to 6 months. Patients who chose to taper were seen more frequently. They all received the routine care available in the clinic which included an award winning supported employment program. It was shared with the clients that their progress was being tracked by their psychiatrist in a systematic way. In addition, during this time, the psychiatrist gave presentations to staff on the rationale as well as the controversies regarding drug tapering.
It was suggested that patients reduce their doses by no more than 25–30% of the initial dose at intervals no more frequent than every 3 months. The rational for this recommendation was based on data from tapering studies where patients were followed for up to 2 years. Most relapses occurred within 3–6 months (Viguera et al. 1997). In addition, a slow taper was hypothesized to reduce risk of supersensitivity psychosis which could happen as a result of antipsychotic induced up regulation of the post-synaptic dopamine receptor (Chouinard et al. 2017). The goal was not necessarily to stop the drug completely but to establish a new minimally effective dose (MED). Patients who were more cautious could reduce at a slower rate. If a patient was able to remain stable for 3–6 months after dose reduction, it was assumed a new MED was established. Decisions were made in a collaborative way and patients were free to stop or begin the taper at any time.
Sources of Data
This is a report of a chart review of those clients who participated in these discussions about drug tapering. During the first 6 months, the author kept track of all patients who had this conversation about drug taper. Current doses and employment status were recorded. In chart review, the author tallied the total number of patients she had seen during those 6 months who were prescribed an antipsychotic drug.
At 5 years, the author reviewed the patients’ charts to determine dose of antipsychotic drug, employment status, and hospitalizations during the previous 5 years. Demographic data was also collected from the record. Antipsychotic drug doses were converted into risperidone equivalents following Woods (2003).
Analysis Plan Including Tests of Significance
Chi square tests were completed for demographic data, rates of hospitalization, and rates of employment. T-tests were used for comparison of doses of antipsychotic drugs.
During the initial six month period, the psychiatrist met with a total of 129 patients in this clinic who were prescribed antipsychotic drugs. Of those, 11 were excluded because they had not been on the drugs for more than a year and 51 were excluded because they were either not clinically stable and/or not considered to have the capacity to engage in a discussion about the risks and controversies involved in a decision to taper their drugs. Of the remaining 67, 40 individuals chose to taper their doses and 27 declined. There were no significant differences in age, sex, race, or percent diagnosed with schizophrenia (Table 1).
Table 2 shows outcome at 5 years with regard to dose reduction, hospitalization and employment status.
Those who chose to taper began and ended on significantly lower doses of antipsychotic drug. There was no statistically significant difference in either hospitalization or employment rate between the groups. There were nine individuals in the taper group who were hospitalized during the 5 years. Of those 9, three had abruptly stopped their drug prior to the hospitalization. All three of them had done this in the past.
Since patients were free to change their minds, some patients who initially wanted to taper subsequently stopped the taper or resumed their initial dose and others who initially did not want to taper decided to start. These decisions were not necessarily due to change in symptoms. In an attempt to obtain further exploratory information, members of the cohort who were still followed in the clinic at 5 years were categorized in four ways according to their status: (1) those who continued to taper through the 5 years, (2) those who had any dose reduction during the 5 years, (3) those who reached a dose of 2 mg risperidone equivalents or less by 5 years, and (4) those who never made any dose reduction during this time period (some individuals met criteria for more than one category). Demographic and outcome data are shown on Table 3. Given the preliminary nature of this data and small numbers, this data was not subjected to statistical inquiry. There is a suggestion that those who were successful in reducing their doses more significantly had a greater likelihood of achieving employment.
Three individuals stopped their drugs completely during this time period. None were hospitalized. Their average age was 41 years. Diagnoses included schizoaffective disorder, post-traumatic stress disorder, and bipolar disorder, manic with psychotic features.
The strongest result of this study is the finding that there are many clients in a typical community mental health center setting who can participate in a discussion about the risks of antipsychotic drugs, including some of the current controversies regarding long-term use, and make individualized decisions about their care. These discussions did not lead to wholesale abandonment of drug treatment. Most patients were cautious. Over time, some patients halted their drug tapering schedules and some who were initially reluctant to make changes decided to try dose reduction.
There was no statistical difference between groups in either outcome measure (rate of hospitalization and employment) but this could be due to the low power of this study. Three of those who were hospitalized had abandoned the taper and abruptly stopped their drugs. This did not appear to be due to the impact of the suggestion to taper since these individuals had done this in the past even when a taper was not suggested. They were individuals who were ambivalent about taking the drugs and it had been hoped that a slow taper might encourage them to adhere to the recommended treatment plan.
While there was no advantage with regard to employment for those who tapered, there was a suggestion that those who were able to reduce most significantly may also have been more likely to be employed. However, the author acknowledges that the numbers are small and this is a correlation which cannot be used to confirm the hypothesis that dose reduction contributes to improved functional outcome.
This was a middle-aged cohort. We do not present years of exposure to drug prior to tapering since this data was difficult to obtain, however, we know that most of these individuals has been taking these drugs for many years. The outcomes might be different for a younger group who had not only less exposure to the drugs but also less time spent out of the work force.
This data is offered as a preliminary investigation into the question as to whether it is feasible to suggest a tapering protocol to those clients in a community mental health care setting who are able to engage in informed consent. This was a chart review and the numbers are small. Due to the nature of the process, it was difficult to collect outcome data other than rates of employment and hospitalization, though such measures are arguably among the most salient. To our knowledge, this is the largest database of patients who have been monitored while tapering antipsychotic drug doses. Given the many concerns about long-term exposure to these drugs, this is a field in need of further study.
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