PubMed HealthSearch

Biomedical subjects

R F Prien

Publications and source records attributed to R F Prien.

At least 19 recordsLinked to original sources

Methodologic issues in maintenance therapy clinical trials.

In the early 1980s, the National Institute of Mental Health supported a multicenter, randomized, controlled, clinical trial on unipolar and bipolar disorder to evaluate the comparative efficacies of lithium carbonate, imipramine hydrochloride, a lithium-imipramine combination, and placebo in preventing the recurrence of affective disorders. The objective of this report is to present a reanalysis of the relative efficacies of these treatments in patients with unipolar disorder to focus attention on general issues related to the design and conduct of maintenance therapy trials. We show that the earlier conclusions of that study that imipramine and the combination therapy are more effective than lithium and placebo in preventing the recurrence of depression in unipolar patients can be accounted for by alternative explanations that are a consequence of the design of the study. Our findings have important implications for the design, conduct, and interpretation of results of maintenance therapy clinical trials in general.

Adult

The definition and operational criteria for treatment outcome of major depressive disorder. A review of the current research literature.

A review of research articles published in nine journals over a 2-year period was conducted to determine how critical changes in the clinical course of depressive disorder are defined in the research literature. These change points, labeled by terms such as response, recovery, and relapse, are critical for evaluation and communication of study results. The review focused on studies of unipolar depression that used a criterion-based diagnostic system and involved some form of therapeutic maneuver. The review showed significant inconsistency in the labeling and definition of change points and indicated the need for more precise conceptual definitions and operational criteria to enhance comparison, generalization, and application of results from clinical studies of depression.

Depressive Disorder

Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence.

In 1988, the MacArthur Foundation Research Network on the Psychobiology of Depression convened a task force to examine the ways in which change points in the course of depressive illness had been described and the extent to which inconsistency in these descriptions might be impeding research on this disorder. We found considerable inconsistency across and even within research reports and concluded that research on depressive illness would be well served by greater consistency in the definition change points in the course of illness. We propose an internally consistent, empirically defined conceptual scheme for the terms remission, recovery, relapse, and recurrence. In addition, we propose tentative operational criteria for each term. Finally, we discuss ways to assess the usefulness of such operational criteria through reanalysis of existing data and the design and conduct of new experiments.

Depressive Disorder

Efficacy of continuation drug therapy of depression and anxiety: issues and methodologies.

Continuation treatment is the continued administration of a drug after disappearance of acute symptoms for the purpose of maintaining control over the episode. This critical phase of treatment constitutes a neglected area of research concerned with depression and anxiety disorders. Most therapeutic studies focus on the treatment of acute symptoms, using designs of only 4-8 weeks' duration. These studies provide little information on the effectiveness and use of continuation treatment for the duration of an episode, which may extend for months following control of acute symptoms. Furthermore, the relatively few continuation drug therapy studies deal primarily with depressive disorders, leaving anxiety disorders almost two decades behind depressive disorders in terms of published research in this critical area of treatment. This report reviews the current status of continuation drug treatment for anxiety and depression and examines research needs, issues, and problems. It also presents a design model for evaluating the need for and duration of continuation treatment for both depressive and anxiety disorders.

Anti-Anxiety Agents

Alternatives to lithium for preventive treatment of bipolar disorder.

The authors review the research literature on drug treatment for the prevention of recurrences in bipolar disorder, emphasizing the available alternatives to lithium therapy. They discuss the need for alternative treatments and the current status of promising agents. Carbamazepine receives special attention because of its status as the most promising backup treatment for lithium. The authors conclude that despite the extensive literature on carbamazepine, there is strong need for carefully designed, prospective, double-blind studies to establish the efficacy of carbamazepine alone and in combination with lithium as a prophylactic treatment for bipolar disorder. Difficulties in developing and evaluating preventive maintenance are discussed.

Anticonvulsants

Continuation drug therapy for major depressive episodes: how long should it be maintained?

A major problem for the practitioner is the lack of satisfactory guidelines as to how long continuation drug treatment of depressive episodes must be maintained to ensure that the episode is over. This often leads to either premature withdrawal of the drug and subsequent relapse or unnecessarily prolonged treatment. Results from a collaborative project of the National Institute of Mental Health provide the first study-derived guidelines on the length of continuation therapy. Findings indicate that withdrawal of such therapy is safe only after the patient has been free of significant symptoms for 16 to 20 weeks and that focusing on mild as well as severe symptoms is critical in this decision.

Adult

Bipolar disorder: are there manic-prone and depressive-prone forms?

Descriptive studies from the prelithium era and lithium prophylactic studies were reviewed to look for evidence that there are manic-prone and depressive-prone subtypes of bipolar illness. The manic-prone subtype has a high ratio of manic to depressive episodes, and a depressive-prone subtype has the reverse. Although data from the prelithium era are suggestive, the evidence is insufficient to accept or reject the relevance of this hypothesis. Data from the lithium era suggest that there is a relationship between the type of index episode and future episode on placebo as well as drug. The clinical and heuristic implications of the relationship of index to subsequent episode and manic proneness and depressive proneness are discussed. Its relevance for planning prophylactic drug studies is also examined. The suggestive evidence presented here will hopefully encourage other investigators to collect the data necessary to test the possibility that manic-prone and depressive-prone subtypes of bipolar illness exist.

Bipolar Disorder

Antidepressant drug therapy: the role of the new antidepressants.

Three new antidepressants have been marketed in the United States since 1980, and about two dozen more are being evaluated. In a 1983 workshop convened by the National Institute of Mental Health, participants examined the claims made for the newer antidepressants in relation to clinical efficacy, speed of onset, cardiovascular effects, and other adverse reactions. In this summary report of the workshop, primarily covering amoxapine, maprotiline, trazodone, and the investigational drug bupropion, the authors note that none of the new antidepressants demonstrate greater effectiveness than standard tricyclics, although some produce a different profile of side effects. The main benefit of the newer drugs is that they offer new options for the treatment of patients who cannot tolerate side effects of the traditional drugs or have responded unsatisfactorily to them.

Amoxapine

Hospital surveys of prescribing practices with psychotherapeutic drugs. A critical examination.

Hospital surveys of psychotherapeutic drug prescribing in the United States have been generally critical of the treatment practices of physicians and have been used to support claims that psychotherapeutic drugs are overprescribed and misused. This report examined several recent multihospital surveys of psychotherapeutic drug use and concludes that the surveys have failed to provide sufficient information to determine the appropriateness of treatment practices. The limitations of these surveys and the need to develop more adequate information about physician prescribing patterns are discussed.

Drug Prescriptions

Relationship between dosage and response to lithium prophylaxis in recurrent depression.

The authors analyzed the results of a multihospital collaborative study on the effectiveness of lithium prophylaxis in recurrent depression in terms of dosage and found that serum lithium levels between 0.5 and 0.7 mEq/liter and doses below 1000 mg/day were relatively ineffective in preventing recurrences. Serum lithium levels between 0.8 and 1.0 mEq/liter and doses above 1000 mg/day were associated with a relatively low failure rate. The authors discuss the relevance of these findings to current prescription guidelines for lithium carbonate.

Bipolar Disorder

The use of psychoactive drugs in elderly patients with psychiatric disorders: survey conducted in twelve Veterans Administration hospitals.

A survey conducted at 12 VA hospitals included the collection of detailed information on the use of psychoactive drugs in 1,276 elderly psychiatric patients. On the day of the survey, 61 per cent of the patients were receiving psychoactive drugs. Prescription practices relating to the choice of drugs, prevalence of drug use, dosage, combination drug preparations, and antiparkinson agents are discussed in terms of such factors as the patient's age and the diagnosis. Also discussed is the literature on psychoactive drugs, particularly as it pertains to elderly populations.

Aged