OBJECTIVE The authors sought to assess the efficacy of functional remediation, a novel intervention program, on functional improvement in a sample of euthymic patients with bipolar disorder. METHOD In a multicenter, randomized, rater-blind clinical trial involving 239 outpatients with DSM-IV bipolar disorder, functional remediation (N=77) was compared with psychoeducation (N=82) and treatment as usual (N=80) over 21 weeks. Pharmacological treatment was kept stable in all three groups. The primary outcome measure was improvement in global psychosocial functioning, measured blindly as the mean change in score on the Functioning Assessment Short Test from baseline to endpoint. RESULTS At the end of the study, 183 patients completed the treatment phase. Repeated-measures analysis revealed significant functional improvement from baseline to endpoint over the 21 weeks of treatment (last observation carried forward), suggesting an interaction between treatment assignment and time. Tukey's post hoc tests revealed that functional remediation differed significantly from treatment as usual, but not from psychoeducation. CONCLUSIONS Functional remediation, a novel group intervention, showed efficacy in improving the functional outcome of a sample of euthymic bipolar patients as compared with treatment as usual.

BackgroundA 12-week, double-blind, parallel, multi-center randomized controlled trial in 316 adult patients with major depressive disorder (MDD) was conducted to evaluate the effectiveness of pharmacogenetic (PGx) testing for drug therapy guidance.MethodsPatients with a CGI-S ≥ 4 and requiring antidepressant medication de novo or changes in their medication regime were recruited at 18 Spanish public hospitals, genotyped with a commercial PGx panel (Neuropharmagen®), and randomized to PGx-guided treatment (n = 155) or treatment as usual (TAU, control group, n = 161), using a computer-generated random list that locked or unlocked psychiatrist access to the results of the PGx panel depending on group allocation. The primary endpoint was the proportion of patients achieving a sustained response (Patient Global Impression of Improvement, PGI-I ≤ 2) within the 12-week follow-up. Patients and interviewers collecting the PGI-I ratings were blinded to group allocation. Between-group differences were evaluated using χ2-test or t-test, as per data type.ResultsTwo hundred eighty patients were available for analysis at the end of the 12-week follow-up (PGx n = 136, TAU n = 144). A difference in sustained response within the study period (primary outcome) was not observed (38.5% vs 34.4%, p = 0.4735; OR = 1.19 [95%CI 0.74-1.92]), but the PGx-guided treatment group had a higher responder rate compared to TAU at 12 weeks (47.8% vs 36.1%, p = 0.0476; OR = 1.62 [95%CI 1.00-2.61]), and this difference increased after removing subjects in the PGx-guided group when clinicians explicitly reported not to follow the test recommendations (51.3% vs 36.1%, p = 0.0135; OR = 1.86 [95%CI 1.13-3.05]). Effects were more consistent in patients with 1–3 failed drug trials. In subjects reporting side effects burden at baseline, odds of achieving a better tolerability (Frequency, Intensity and Burden of Side Effects Rating Burden subscore ≤2) were higher in the PGx-guided group than in controls at 6 weeks and maintained at 12 weeks (68.5% vs 51.4%, p = 0.0260; OR = 2.06 [95%CI 1.09-3.89]).ConclusionsPGx-guided treatment resulted in significant improvement of MDD patient’s response at 12 weeks, dependent on the number of previously failed medication trials, but not on sustained response during the study period. Burden of side effects was also significantly reduced.Trial registrationEuropean Clinical Trials Database 2013-002228-18, registration date September 16, 2013; ClinicalTrials.gov NCT02529462, retrospectively registered: August 19, 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-017-1412-1) contains supplementary material, which is available to authorized users.

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We examined the relationship between gambling severity, impulsivity and obsessionality/compulsivity in thirty-eight pathological gamblers, comprising the complete Minnesota sample of a randomized, placebo-controlled clinical trial of paroxetine for the treatment of Pathological Gambling (PG), using Pearson correlations and linear regression models at baseline and treatment endpoint. At baseline, Pathological Gambling Modification of the Yale-Brown Obsessive-Compulsive Scale (PG-YBOCS) scores correlated significantly with those of the Eysenck Impulsiveness Questionnaire (EIQ) Impulsiveness subscale and Padua Inventory (PI) factors I and IV (corresponding to impaired control over mental and motor activities, respectively). None of the associations between PI factors and the PG-YBOCS were significant after adjusting for Impulsiveness scores. There were no differences in changes in the PG-YBOCS between the paroxetine and placebo group. Changes in PG-YBOCS scores after treatment correlated with changes in Impulsiveness scores. These changes appeared independent of paroxetine treatment. These results suggest that, although PG exhibits features of both obsessionality/compulsivity and impulsivity and elements of both decrease with treatment, impulsivity predominates and changes in gambling severity are most associated with changes in impulsivity.

Psychiatric comorbidity is common among pathological gamblers and is associated with greater severity of clinical problems. The DRD(2) gene could be a liability genetic factor for psychiatric comorbidity in pathological gambling.

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Previous studies have suggested the efficacy of serotonergic agents in the treatment of pathological gambling. The aim of the present study was to determine whether treatment with paroxetine in a large sample of subjects with pathological gambling would effectively diminish the severity of gambling symptoms. A 16-week, double-blind, placebo-controlled trial was conducted at five outpatient academic research centres in two countries (USA and Spain). Seventy-six outpatients (mean age 45.4+/-10.6 years; 30 women, 46 men) with pathological gambling were randomized to acute treatment with paroxetine in flexible daily dosages of 10-60 mg/day (n=36) or placebo (n=40). The primary outcome measure was the Clinical Global Impressions scale. Both the paroxetine- and the placebo-treated groups demonstrated comparable improvement at 16 weeks (59% response rate in the paroxetine group, 49% rate in the placebo group; chi squared=0.737; d.f.=1; P=0.390). Paroxetine consistently resulted in a greater percentage of responders at each study visit compared to placebo but failed to demonstrate statistical superiority to placebo on scores on the Clinical Global Impressions scale, the Yale-Brown Obsessive-Compulsive Scale Modified for Pathological Gambling, or the Gambling Symptom Assessment Scale. High rates of symptom improvement were observed in pathological gamblers receiving either paroxetine or placebo after 16 weeks. Paroxetine consistently demonstrated an advantage over placebo on the Clinical Global Impressions scale; however, a larger sample size may have registered significant differences.