A Randomized Comparative Study In Depressed Outpatients With Insomnia Who Received The Treatment Of Paroxetine In Combination With Or Without Low Dose Olanzapine

ObjectiveInsomnia appears to be one of the most prevalent symptoms and physical signs of depression which was proved to have bilateral link with insomnia.Nowadays, new kinds of antidepressants,(eg. SSRIs、SSNIs、NaSSAs),which are widely used in depressed patients can effectively relieve depressive symptoms.But these effects are often observed2-4weeks after the treatment was given,and fewer effects on sleep disorder improve are shown especially in the early treatment. The atypical antipsychotic drug olanzapine which can increases sleep continuity and enhances slow wave sleep (SWS) in healthy subjects, has been employed as an augmentation treatment in depressed patients unresponsive to treatment with selective serotonin reuptake inhibitors (SSRIs). The aim of the present study was to compare the treatment effects among depressed outpatients with insomnia treated with or without low dose olanzapine in addition to paroxetine.Methods1. Object1.1Depressive group:171cases, with an average age (41.6±13.4) years,were sampled from patients visiting neurology outpatient clinic, Qi Lu Hospital of Shandong University, from September2010to August2011,and meet the inclusion criteria and the exclusion criteria.171cases was divided into two groups.There were88patients in Combination group (average aged40.17±13.6years) and83cases in Paroxetine group(average aged43.1±13.0years).1.2Control group:102cases, with an average age (42.1±13.7) years, were sampled from students of Shandong University, Employees of Qi Lu Hospital and examinees of Medical examination center of Qi Lu Hospital. The score of HAMD should be less than7,examination result of routine blood test, liver and renal function, electrocardiogram (ECG) and blood pressure should be normal; with no history of schizophrenia and alcohol/drug dependence or abuse; meet the prior exclusion criteria.2. Scale measureThe assessment of HAMD, HAMA, PSQI was administrated to all patients at baseline and after treatment of1st month,3rd month and6th month.Subjects in control group received HAMD, HAMA, PSQI assessment only once at baseline.3. TreatmentParoxetine group was given paroxetine20mg, qd and oryzanol20mg qn; Combination group was given paroxetine20mg, qd and olanzapine2.5mg qn.4. StatisticsAssociation analysis was performed by using SPSS20.0software. Measurement data were shown in the form of mean±standard deviation(x±s)and the compairation between groups were conducted by the way of t-test for independent samples, Ridit-test for efficacy analysis, and the copairation between outcomes before and after treatment in each group were conducted by the way of one-way analysis of variance(One-way ANOVA). Enumeration Data were shown in the form of rate and the comparison between groups were conducted by the way of chi-square test (χ2test); P<0.05was statistically significant.Result 1.At baseline when patients were enrolled in, there was no statistical difference on the total score of HAMD scale (30.59±4.85vs.31.67±5.82)、PSQI score (14.60±3.21vs.15.13±2.52), HAMA score (15.90±3.23vs.15.69±4.34) between paroxetine group and Combination group (P>0.05); there were no statistical difference on the score of the sleep disorder agent and anxiety agent of HAMD(P>0.05)。2.After6months week treatment, the PSQI score of paroxetine group reduced (9.05±0.21) while it reduced(11.27±0.25) in Combination group. There was statistical difference between two groups on total score of PSQI and scores of agents(subjective sleep quality, sleep latency, Sleep efficiency, sleep maintenance)(P<0.05).There was statistical difference on total score of HAMD of both groups comparing with the score before treatment (P<0.05). After6months’treatment the total score of HAMD、 PSQI、HAMA of both groups obviously reduced compared with the scores before treatment, with a statistical difference. The treatment of paroxetine combining with olanzapine was effective, with a better tolerance after6months’ treatment, and group was significant. The rate of improvement on treatment of combination group after6months treatment was88.6%on HAMD, while it was78.4%on HAMD of the paroxetine group. The rates of improvement on the symptom of anxiety of both groups were (89.8%vs.85.5%).ConclusionThe combination therapy of paroxetine and olanzapine for depression with (?)nsomnia has an augment effect for the treatment of depressive symptoms and (?)nsomnia. It improves the subjective sleep quality of depressive patients in either nitial period or long-term treatment period. Meanwhile, the combination therapy of...