Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial

Introduction The response to placebo is robust in studies of various antidepressant treatments. The strong placebo response, combined with the absence of side-effects, has prompted suggestions to use the ethically sound open-label placebo (OLP) as a treatment for depression. Objectives The aim of the present study was to assess the efficacy of OLP in the setting of a randomized controlled trial for the treatment of unipolar depression. Methods Thirty-eight patients (28 females, 73.7%) were randomized to either an eight-week treatment with OLP (n=18) or four week of treatment as usual (TAU) followed by four weeks of OLP (n=20). Clinical and socio-demographic measures were assessed at baseline, after four weeks, and at the end of the trial. Response to treatment was determined using the Quick Inventory of Depressive Symptomatology (QIDS SR-16). Results There was an overall decrease in depression levels over time, F(2,35) = 3.98, p = .028). A significant group x time interaction was found only among non-geriatric patients (<65y) with an early onset of depression (<50y), F(2,22) = 3.89, p = .036]. Post-hoc tests indicated a significant decrease during the first four weeks, but only in the OLP group, t(11) = 2.29, p = .043. Table 1: Demographic measures of OLP and TAU patients. Measures OLP (n = 18) TAU (n =20) Statistical analyses Age (years) [Mean ± SD] 48.17 ± 16.86 51.65 ± 17.68 t(36) = -0.62, p = .539 Education level (years) [Mean ± SD] 15.61 ± 3.66 14.22 ± 2.62 t(34) = 1.31, p = .200 Gender (male/female) [no.] 4 / 14 6 / 14 X2(1) = 0.30, p = .587 Age of onset (years) [Mean ± SD] 34.19 ± 15.82 32.45 ± 17.72 t(36) = 0.32, p= .752 Number of depressive episodes (no.) [Mean ± SD] 2.58 ± 2.61 6.64 ± 9.16 t(21) = -1.47, p = .156 Number of hospitalizations (no.) [Mean ± SD] 0.12 ± 0.33 0.17 ± 0.38 t(33)= -0.40, p = .689 Notes OLP = Open label placebo; SD = Standard deviation; TAU = Treatment as usual. Image 3: Conclusions Our findings support the possibility that OLP is an effective treatment for the relatively young population of patients suffering from depression. Additional studies are warranted in order to explore the use of open-label placebo in clinical work. Disclosure of Interest None Declared

Introduction: Transcranial magnetic stimulation (TMS)is perhaps the most popular of the newbrain stimulation techniques because its clinical effects are produced without the need for a craniotomy (as with deep brainstimulation (DBS)) or seizure induction(as with electroconvulsive therapy (ECT)).Recently ,TMS is typically used to improve depression symptoms when other depression treatments haven't been effective.Objectives: This is a review that discuss the efficacy of the antidepressant effect of TMS.Methods: A narrative review was conducted basedon a search in pubmed using thekeywords: "rTMS" and "depression".Results: One of the reviews studied proved the efficacy of rtms in the treatment of depressionbut there is still a clinical need for the complementary use of antidepressants.Although rTMS is more expensive than conventional antidepressants, it remains more interesting for patients who have not found benefits with pharmacological treatments.The other review also demonstrated the antidepressant effect of rTMS and that this effect, once completed, appears to be as long-lasting as that of antidepressants.TMS is also a promising new therapy and a powerful research tool.The body of TMS literature suggests that daily, left prefrontal TMS for 3-6 weeks has antidepressanteffects that are clinically meaningful (30% remission), with low side effects and nodrug-drug interactions.Furthermore, TMS shows promise in several other psychiatricdisorders, particularly treating acute and chronic pain.
Conclusions: Even though The Food and drug administration (FDA) has accorded RTMS' initial clearance of the first device in 2008 ,additional researches are still needed.The TMS coil location, stimulation intensity and frequency, and dosing strategy have to be more precise for better results.

EPV0457
Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial

Introduction:
The response to placebo is robust in studies of various antidepressant treatments.The strong placebo response, combined with the absence of side-effects, has prompted suggestions to use the ethically sound open-label placebo (OLP) as a treatment for depression.Objectives: The aim of the present study was to assess the efficacy of OLP in the setting of a randomized controlled trial for the treatment of unipolar depression.Methods: Thirty-eight patients (28 females, 73.7%) were randomized to either an eight-week treatment with OLP (n=18) or four week of treatment as usual (TAU) followed by four weeks of OLP (n=20).Clinical and socio-demographic measures were assessed at baseline, after four weeks, and at the end of the trial.Response to treatment was determined using the Quick Inventory of Depressive Symptomatology (QIDS SR-16).
Results: There was an overall decrease in depression levels over time, F(2,35) = 3.98, p = .028).A significant group x time interaction was found only among non-geriatric patients (<65y) with an early onset of depression (<50y), F(2,22) = 3.89, p = .036].Post-hoc tests indicated a significant decrease during the first four weeks, but only in the OLP group, t(11) = 2.29, p = .043.Introduction: Treatment Resistant Depression (TRD) is a complex, heterogeneous and multifactorial clinical condition that affects patients' quality of life, their psychosocial functioning as well as suicidal risk.Intranasal esketamine is a new add-on treatment specifically approved for TRD.
Objectives: The aim of the study was to evaluate the efficacy and safety of intranasal esketamine treatment combined with intensive Cognitive Behavioral psychotherapy (CBT), together with treatment satisfaction, in two complex clinical cases of TRD with high suicidal risk in a 12 months follow-up.Methods: Two male patients, 67 and 63 years old, with TRD, defined by at least two therapeutic failures with SSRI/SNRI and positive screening for high suicidal risk at the Columbia Suicide Severity Rating Scale, were selected for treatment with intranasal esketamine þ CBT as an add-on to SSRI/SNRI antidepressant therapy.Psychopathological assessment were made by means of Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Columbia Suicide Severity Rating Scale (C-SSRS), Clinical Global Impression (CGI), Short Form Health Questionnaire (SF-36 items) at T0, every 7 days for the first 3 months, then every month.Treatment satisfaction was evaluated by means of the Client Satisfaction Questionnaire (CSQ-8), administered by trained nursing staff at 1, 3, 6 and 12 months.CBT specifically focused on depression was administered by a certified psychotherapist, weekly for the first 4 months, fortnightly for the next 3 months, monthly for the remaining 3 months.
Results: After 2 administrations of esketamine the total HAM-D score was reduced by an average of 10 units and the suicidal risk was progressively reduced to zero according to C-SSRS.After 12 months one of the two patients reached and actually maintains clinical remission; the other one maintains a condition of mild depression; both without suicidal ideation and with a significant increase in perceived quality of life.Treatment was well tolerated, with mild and temporary adverse effects, self-limited to the administration sessions.CBT has contributed to increasing insight, cognitive resources, social interaction and self-esteem, and has made it possible to structure and carry on new life projects.The variation of the mean scores for CSQ-8 shows that esketamine þ CBT treatment was considered as very satisfactory throughout the observation period.
Conclusions: Intranasal esketamine associated with intensive CBT sessions showed to be effective, safe and satisfactory in the real world clinical management of two complex cases of TRD with high suicidal risk, improving quality of life, social functioning and eliminating suicidal ideation within 12 months followup.Satisfaction with the treatment contributed to strengthening adherence and improving the operator-patient therapeutic relationship.
Disclosure of Interest: None Declared

EPV0459
Self-esteem is associated with loss of autonomy and depression in the elderly W. BOUALI1 *, M. KACEM 1 , W. HAOUARI2 and L. ZARROUK 1 Introduction: Self-esteem is an important aspect of adaptive processes at all ages of life and particularly in older adults: it is linked to the quality of adaptation, well-being, life satisfaction and health.
Objectives: study the links between self-esteem, autonomy and depression in the elderly Methods: This is a descriptive and analytical study carried out over four months in the offices of three doctors.The population of the

Table 1 :
Demographic measures of OLP and TAU patients.