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Intranasal esketamine + Intensive CBT: a 12 months follow-up of two complicated cases of Treatment Resistant Depression at high suicidal risk
- V. Martiadis, F. Raffone, R. Cerlino, S. Testa, M. Russo
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- Journal:
- European Psychiatry / Volume 66 / Issue S1 / March 2023
- Published online by Cambridge University Press:
- 19 July 2023, p. S846
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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.
ObjectivesThe 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.
MethodsTwo 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 + 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.
ResultsAfter 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 + CBT treatment was considered as very satisfactory throughout the observation period.
ConclusionsIntranasal 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 follow-up. Satisfaction with the treatment contributed to strengthening adherence and improving the operator-patient therapeutic relationship.
Disclosure of InterestNone Declared
Cariprazine add-on for resistant bipolar depression: preliminary results from an italian real-world experience
- V. Martiadis, E. Pessina, A. Martini, F. Raffone, D. De Berardis
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- Journal:
- European Psychiatry / Volume 66 / Issue S1 / March 2023
- Published online by Cambridge University Press:
- 19 July 2023, p. S274
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Introduction
Depressive episodes represent the most frequent mood alteration in bipolar disorder (BD). Persistent depressive episodes and subsyndromic depressive symptoms often lead to poor quality of life and increase suicide risk. Recent studies have also shown that BD patients with a history of predominant depressive episodes generally show poorer response to pharmacological treatments. Although not specifically approved in Italy for use in bipolar depression, the scientific literature produced so far suggests the possible use of cariprazine in clinical conditions of bipolar depression that do not respond to conventional treatments.
ObjectivesThe aim of the study was to evaluate, in a real-world multicentric Italian clinical setting, the efficacy and safety of cariprazine augmentation strategy in a sample of patients suffering from treatment-resistant bipolar depression.
Methods16 resistant bipolar depressed patients, whose resistance was defined according to The CINP Guidelines on the Definition and Evidence-Based Interventions for Treatment-Resistant Bipolar Disorder, were observed for 4 weeks after the add-on to previous mood stabilizing treatment of a cariprazine 1,5 mg fixed dose. Psychopathology at time 0 and at 1, 2, 3, and 4 weeks of treatment was evaluated using the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Young Mania Rating Scale and the Brief Psychiatric Rating Scale; safety and tolerability of the therapy was measured by the UKU Side Effect Rating Scale.
ResultsClinical improvement induced by 1,5 mg cariprazine add-on was effective and well tolerated in the study sample. Improvement in depression scores started from the first week, reaching about 35% reduction within 15 days and almost 50% in the following weeks (mean HDRS score from 24,7 to 13,2, GLM r.m. p<0,001); global psychopathology improved (mean BPRS score from 29,9 to 15,3 GLM r.m. p<0,001) as well as anxiety symptoms (mean HARS score from 26,5 to 16,5 GLM r.m. p=0,003). No manic shifts were observed during the observation period and the treatment was generally well tolerated.
ConclusionsDespite the small number of patients examined and the short term of observation, cariprazine could represent an effective and safe enhancement strategy for patients with bipolar depression resistant to common pharmacological treatments. Further studies on larger samples are needed to confirm these preliminary findings. In addition, a more prolonged observation would be appropriate to highlight whether the beneficial effect of cariprazine add-on persists over time.
Disclosure of InterestNone Declared
Brexpiprazole augmentation in a clozapine-resistant young schizophrenic patient: a successful case report.
- V. Martiadis, F. Raffone, M. Russo
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- Journal:
- European Psychiatry / Volume 66 / Issue S1 / March 2023
- Published online by Cambridge University Press:
- 19 July 2023, p. S1091
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Introduction
Although clozapine is considered the most effective drug for Treatment Resistant Schizophrenia (TRS), only 40% of patients treated will meet clinical response. Literature reviews and meta-analytic data offer no definite conclusions about the most effective clozapine augmentation strategies. Nevertheless, it has been suggested that the lack of evidence should not discourage clinicians from trying out new strategies in individual patients. Brexpiprazole is a novel 5-HT and DA modulator antipsychotic that exhibits partial agonism to D2/D3 and 5HT1A receptors, antagonism to 5HT2A and α-1B/2C receptors and represents a promising new drug in the pharmacotherapy of schizophrenia for both acute and maintenance treatment. In current literature there is no evidence of experiences in brexpiprazole augmentation for clozapine resistant patients.
ObjectivesThis case report describes a successful clinical experience of brexpiprazole augmentation in a complicated case of clozapine resistant paranoid schizophrenia with consistent negative symptoms, the clinical evolution and metabolic improvement consequent to this therapy combination.
MethodsIn a 27 male TRS patient, sequentially treated with adequate doses of risperidone, cariprazine, aripiprazole and olanzapine monotherapy, prescribed for adequate time, clozapine treatment was started, with a gradual titration from 25 to 300 mg/day, without significant clinical response on both positive and negative symptoms. Successively was introduced fluoxetine, from 10 to 30 mg/day, with no relevant clinical improvement. After 2 months of pharmacological stabilization with clozapine and fluoxetine described dosages, brexpiprazole was introduced starting from 1 mg/day and rapidly increasing till 4 mg/day.
ResultsAfter 6 weeks of treatment, PANSS positive and negative subscales showed a significant decrease, respectively from 28 to 17 and from 42 to 20, while general psychopathology subscale decreased from 66 to 34. Negative sub-items with major improvement were those regarding blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal. Brexpiprazole augmentation also allowed to slowly decrease (in 6 months) clozapine dose till actual 150 mg/day, with a significant improvement in general tolerability and a slow decline in metabolic parameters (BMI from 36.5 to 30.3; fasting glucose from 112 to 92 mg/dL; total cholesterol from 248 to 182 mg/dL; total triglycerides from 392 to 198 mg/dL).
ConclusionsIn this case report brexpiprazole augmentation in a clozapine resistant young schizophrenic patient was an effective strategy with significant symptoms improvement, in particular in PANSS general psychopathology and PANSS negative subscales. The consequent clozapine dose reduction contribute to the slow decrease in metabolic parameters considered.
Disclosure of InterestNone Declared
Metacognition, emotional dysregulation, psychosocial functioning and subjective well-being after 6 months of CBT treatment in pharmacologically stabilized schizophrenic patients
- F. Raffone, A. Orrico, M. D’Orsi, S. Ferro, M. Russo, V. Martiadis
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- Journal:
- European Psychiatry / Volume 66 / Issue S1 / March 2023
- Published online by Cambridge University Press:
- 19 July 2023, pp. S370-S371
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Introduction
Psychoses represent serious psychiatric disorders in which an individual perceptions, thoughts, mood and behavior are significantly altered. Each person who develops a psychosis lives a unique set of symptoms and experiences that may widely vary depending on life circumstances. Although cognitive behavioral psychotherapy (CBT) for psychosis is recommended by main international guidelines, its effectiveness in real-world is still a subject of controversy.
ObjectivesThe aim of this study was to evaluate, in an Italian outpatient clinical setting, eventual improvements induced by a 6 months intensive CBT specific programme focused on metacognition and emotional regulation and its consequences on psychosocial functioning and subjective well-being in pharmacologically stabilized psychotic patients.
MethodsEight patients with schizophrenia spectrum disorders (DSM-V), clinically and pharmacologically stabilized, were included in a 6-month program of weekly CBT sessions with focus on metacognition, emotional dysregulation, social functioning and subjective well-being. Patients were assessed with the Metacognitions Questionnaire-30, Difficulties in Emotion Regulation Scale, Heinrichs Quality of Life Scale, The Psychological General Well-Being Index, Brief Psychiatric Rating Scale, Hamilton Depression Rating Scale at baseline and at 3 and 6 months, to verify any improvement on these specific domains and, possibly, on general psychopathology.
ResultsIn this study CBT showed to be effective on all domains evaluated, most notably for younger patients with a short history of disease (<5 years). Metacognitive capacity was the dimension with most evident improvements, followed by the ability to modulate emotions and the consequent improvement in psychosocial functioning and perceived subjective well-being. During the 6 months follow-up none of the enrolled patients experienced symptoms exacerbation or psychotic relapses.
ConclusionsIn conclusion, the 6-month CBT treatment showed to be effective for stabilized psychotic patients, improving metacognitive functions, emotional regulation, psychosocial functioning, and subjective well-being. In addition, insight, adherence and the therapeutic alliance improved. The absence of psychotic relapses is not attributable with certainty to the effect of CBT since, for this purpose, longer duration studies on larger case series and with RCT methods are required. However, it is plausible that the improvement obtained in disease awareness and adherence may be a facilitating factor in relapse reduction.
Disclosure of InterestNone Declared
LAI-2 adjunctive treatment for type I Bipolar patients with comorbid Obsessive Compulsive Disorder: preliminary data from a real-world multi-centric Italian clinical experience
- V. Martiadis, E. Pessina, A. Martini, F. Raffone, P. Giunnelli, D. De Berardis
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- Journal:
- European Psychiatry / Volume 66 / Issue S1 / March 2023
- Published online by Cambridge University Press:
- 19 July 2023, p. S712
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Introduction
Comorbidity with Obsessive Compulsive Disorder (OCD) in patients with bipolar disorder (BD) affects from 10 to 20% of the clinical samples considered. The pharmacological treatment of these patients emphasizes the clinical issue of the use of serotonergic anti-obsessive agents, which may increase the risk of manic/mixed episodes or may accelerate a rapid cycle course. In some cases, the addition of a second stabilizer drug results in improvement in both mood disorder and comorbid obsessive psychopathology. Although off-label, the use of II generation long-acting injectable antipsychotics (LAI-2) in type I BD is widespread in clinical practice but data regarding their efficacy in improving obsessive symptoms of the eventual comorbid disorder are still lacking.
ObjectivesThe aim of this open-label naturalistic study was to evaluate the efficacy and safety of adjunctive treatment with LAI-2 monthly paliperidone palmitate (PP1M-LAI) and monthly aripiprazole (ARI-LAI) in 24 bipolar type I BD patients with OCD comorbidity, in a real-world clinical setting of 3 outpatient services located in the 3 macro-areas of Northern, Central and Southern Italy.
MethodsTwenty-four patients diagnosed with type I BD and comorbid OCD were recruited and observed over a 24-week period after the add-on of PP1M-LAI or ARI-LAI to stabilizing therapy. Psychopathology assessment was performed by means of Yale-Brown Obsessive Compulsive Scale (YBOCS), Hamilton Depression Rating Scale (HDRS), Brief Psychiatric Rating Scale (BPRS), Young Mania Rating Scale (YMRS), Hamilton Anxiety Rating Scale (HARS). The mean PP1M-LAI dosage was 117.8 mg/month while that of ARI-LAI was 400 mg/month.
ResultsAt the end of the observation period, all patients who completed the study demonstrated a consisten reduction in obsessive symptoms while maintaining effective mood stability in the absence of signs of hypomanic/manic change (YBOCS mean reduction 24,5 to 16,2, GLM r.m. p<0.001; HDRS mean reduction 19 to 10, GLM r.m. p<0.001; YMRS mean reduction from 23,2 to 6,3, GLM r.m. p<0.001). The relatively small number of patients recruited did not allow to detect significant differences in the performance of PP1M and ARI-LAI. Overall tolerability was good for both treatments, in line with the tolerability profiles of each drug.
ConclusionsWhile considering the limitations of the relatively small sample and the open-label design, the results of this study indicate that the two LAI-2, PP1M and ARI-LA,I can be considered an effective and well-tolerated treatment in type I BD patients with OCD comorbidity, confirming efficacy in mood stabilization and reducing obsessive symptoms. Further studies on larger samples will be needed to confirm these preliminary findings and to detect any performance difference between the two antipsychotics.
Disclosure of InterestNone Declared
Intranasal Esketamine + CBT: a 6 months follow-up of a resistant depression complicated case
- V. Martiadis, F. Raffone, R. Cerlino, F. Mistico, M. Russo
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- Journal:
- European Psychiatry / Volume 65 / Issue S1 / June 2022
- Published online by Cambridge University Press:
- 01 September 2022, p. S559
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Introduction
TRD is a highly disabling condition, often responsible for chronic clinical course, high number of relapses and elevated suicide risk. Intranasal esketamine is currently the only available pharmacological therapy specifically indicated for TRD, as add-on therapy to antidepressant treatment with SSRI or SNRI.
ObjectivesThe purpose of the study was to evaluate the safety and efficacy of intranasal esketamine associated with CBT in a complex clinical case of TRD, over a six-month follow-up.
MethodsA 67-year-old patient with TRD was selected for treatment with intranasal esketamine+CBT as add-on to antidepressant therapy. Before each treatment session the HAM-D rating scale was administered. The patient underwent weekly CBT sessions throughout the 6 months follow-up. The effect on physical well-being and social functioning was evaluated by means of Short-Form-Health-Survey-36.
ResultsAfter the first two administrations of intranasal esketamine the total score on HAM-D decreased by 10 units (from 26 to 16). After 6 weeks of treatment decreased from 26 to 12 with the disappearance of suicidal ideation present at T0. After 6 months the total HAM-D score decreased from 26 to 8. Treatment was well tolerated, with mild adverse effects, confined to the first two hours post-administration. In particular, mild sedation, dizziness, slight transient blood pressure rise were reported, never required medical intervention and resolved spontaneously during the observation period.
ConclusionsIntranasal esketamine add-on therapy + CBT was an effective and safe treatment allowing to achieve and maintain symptomatic remission in a complex case of TRD, improving quality of life, social functioning, and reducing suicidal ideation over a six-month follow-up.
DisclosureNo significant relationships.