It remains difficult to determine in what measure improvements observed in clinical trials of anti-depressants may be attributable to the psychological predispositions of the subjects. The present article focuses on the effect of a psychological variable, the Health Locus of Control, which measures the extent of a subject's belief that he is in control over his own health. The hypothesis is that depressed subjects whose locus of control is internal, i.e. who perceive themselves to be in control, rather than external, i.e. control perceived as being in others or just chance, will improve more markedly and consistently on the Hamilton Depression Rating Scale, across a number of clinical trials. Forty-nine depressive patients undergoing treatment with four different compounds were included, after a week's placebo run-in period, in a classical 42-day follow-up study comprising visits on days -7, 0, 10, 21; and 42. Interactions between the type of locus of control and the clinical course were investigated by MANOVA. Results show that with a classical design of clinical trials of antidepressants, locus of control plays a significant role if it is internal (P< 0.001) in consolidating the improvement process, and that this is true irrespective of type of antidepressant. The relationship between the concept of locus of control and placebo effect is discussed.
Background: Cariprazine is a new atypical antipsychotic drug approved for the treatment of schizophrenia and bipolar disorders. Methods: we searched the published randomized controlled-trials (RCT) to review cariprazine efficacy and tolerability using the databases (PubMed, EUDRACT, ClinicalTrials.gov and Cochrane Central Register of Controlled Trials) for cariprazine role in managing the following psychiatric conditions (schizophrenia, bipolar mania, bipolar depression and major depressive disorder). A meta-analysis was conducted using the identified 13 clinical trials to assess efficacy using with the outcomes: positive and negative syndrome scale (PANSS), clinical global impressions -severity of Illness (CGI-S), young mania rating scales (YMRS), Montgomery Asberg depression rating scale (MADRS) and Hamilton rating scale for depression (HAM-D). The risk of discontinuation due to adverse effects and common side effects were examined.Results: The mean difference in change from baseline for PANSS was -6.23 (95% Confidence Interval (CI) -7.18, -5.28) favoring cariprazine treatment (p<0.00001). Similarly, mean difference for CGI-S was -0.36 (95% CI -0.41, -0.30), , ) and . The risk ratio (RR) of discontinuing due to adverse events was 1.18 (95% CI 1.01, 1.38) meaning risk increased by 18% in cariprazine group with RR for EPS related side effects 2. 82 (95% CI 2.47, 3.22) reflecting an increased risk of experiencing EPS related side effects by 182%. Cariprazine was also associated with an increased incidence of side effects such as akathisia, nausea and insomnia.Conclusion: Cariprazine demonstrates significant improvements in symptom intensity control in patients suffering from psychiatric conditions including schizophrenia, bipolar disorders and depression and is considered well-tolerated with similar rates of trials discontinuation; however, cariprazine was associated with a higher risk of EPS side effects. These findings will guide psychiatrists and pharmacists in their clinical role for supporting psychiatric patients care.
Decreased immunity in depressive as compared with control subjects has been well documented, although some depressed patients have severe alterations whereas others have milder ones or not at all. Since for equal severities of depression, there may be individual differences in the degree of perceived control over one's condition, we investigated the interaction of perceived control with immunological variations. Immune function (T and B lymphocytes, lymphocyte proliferation and natural killer cell activity (NKCA)) were evaluated in 34 adult major depressives and in 18 healthy controls. Lymphocyte proliferation did not differ between the two groups, but NKCA was significantly lower in the depressed patient group. Among the depressed subjects, those who experienced less subjective control also showed significantly lower NKCA. An internal locus of control appears to act as a buffer against the decrease in cellular immunity observed in major depression. Further studies should focus on methods of coping and on degree of perceived control rather than on diagnostic and nosographic variables alone.
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