Treatment of aggression with topiramate in male borderline patients, part II: 18-month follow-up.

OBJECTIVE: We previously tested topiramate, an anticonvulsant, in the treatment of aggression in men with borderline personality disorder (BPD) (Nickel M, Nickel C, Kaplan P, Lahmann C, Mühlbacher M, Tritt K, et al. Treatment of aggression with topiramate in male borderline patients: a double-blind, placebo-controlled study. Biol Psychiatry 2005;57:495-9), and found significant changes on most scales of the state-trait anger expression inventory (STAXI) and significant weight loss eight weeks later. The aim of this trial was to assess topiramate's efficacy in the long-term therapy for aggression in men with BPD. METHODS: This 18-month follow-up observation, in which the previous patients (topiramate group: n=22; former placebo group: n=22) were examined bianually, was carried out. RESULTS: According to the intent-to-treat principle, significant changes on all scales of the STAXI were observed in the subjects treated with topiramate. Additional significant weight loss was observed. All subjects tolerated topiramate relatively well. CONCLUSIONS: Topiramate appears to be an effective, relatively safe agent in the long-term treatment of patients with BPD. Mild, non-transient weight loss can be expected.

Aripiprazole in treatment of borderline patients, part II: an 18-month follow-up.

RATIONALE: Only one controlled trial is known that employed aripiprazole for patients with borderline personality disorder (BPD). This 8-week trial found significant changes on most scales of the symptom checklist (SCL-90-R), Hamilton depression rating scale (HDRS), Hamilton anxiety rating scale (HARS), and on all scales of the state-trait anger expression inventory (STAXI). OBJECTIVES, MATERIALS, AND METHODS: To assess the long-term effectiveness of aripiprazole with multifaceted borderline symptomatology, this 18-month follow-up observation with biannual testing was carried out with the same patients from the previous trial (treated with 15-mg aripiprazole daily, n = 26, 21 female and 5 male patients; previous placebo group, n = 26, 22 female and 4 male patients). RESULTS: According to the intent-to-treat principle, significant changes on all scales of the SCL-90-R, HDRS, HARS, and STAXI were observed in the aripiprazole-treated subjects after 18 months. CONCLUSION: Aripiprazole appears to be an effective and relatively safe agent in the long-term treatment of patients with BPD.

Suicide attempts versus suicidal ideation in bulimic female adolescents.

BACKGROUND: Suicide attempts by adolescents continue to be a major public health problem. The purpose of this study was to examine the difference in the family functioning and sociopsychopathological risk factor relationship between female bulimic adolescents with suicidal ideation only, and those who attempted suicide. METHODS: A group of 211 patients were observed for 12 months. Data from 63 subjects (SUG [suicide group], age 17.2 +/- 1.3 years) who had attempted suicide were then compared with 148 (control group, age 18.1 +/- 1.5 years) who had expressed suicidal ideation but did not follow through. RESULTS: Those in the suicide attempt group had been exposed more frequently to physical/sexual violence in childhood. As adults they either lived alone or were dissatisfied with their partnership. The frequency of borderline personality disorders and depressive disorders in this group was significant. Psychosomatic symptoms, disturbed coenesthesia, substance abuse, social impairment and interference with their perception of their own life circumstances, as well as their job performance, often preceded the suicide attempt. Nine genuine risk factors that occurred significantly more often in the SUG were calculated out of all the stress factors using stepwise logistic regression: 'as a child I was even hit with a stick or whip', 'I had no set orientation in life', 'I had a feeling of loneliness despite family and friends', 'I could not relax', 'incapable of dealing with the public', 'I do not like to be touched', 'parents have psychiatric disorders', 'misuse of stimulants', and 'as a child I felt lonely' (odds ratio, 10.56-1.90). CONCLUSION: Adverse family experiences and multiple sociopsychopathological factors may increase the risk of suicide in female bulimic adolescents.

Influence of family therapy on bullying behaviour, cortisol secretion, anger, and quality of life in bullying male adolescents: A randomized, prospective, controlled study.

OBJECTIVE: To determine the influence of brief strategic family therapy (BSFT) on salivary cortisol, anger, and health-related quality of life (QoL) in adolescent boys with bullying behaviour. METHOD: We selected a sample of 72 boys demonstrating bullying behaviour from the general population and treated 36 with BSFT for 12 weeks. The other 36 boys formed the control group. Primary outcome measures were salivary cortisol concentration 15 to 30 minutes after awakening and changes on the subscales of the State-Trait Anger Expression Inventory (STAXI) and the Health Survey (SF-36). RESULTS: After 12 weeks' treatment, we observed a significant reduction in bullying behaviour in the BSFT group (P = 0.017) and in the mean values (according to the intent-to-treat principle) for salivary cortisol concentration (P < 0.001). The BSFT group also showed significantly greater change on the STAXI subscales State-Anger (P < 0.001), Trait-Anger (P < 0.001), Anger-Out (P < 0.001), and Anger-Control (P < 0.001). Treatment with BSFT also resulted in significant improvement on the SF-36 subscales for Vitality (P < 0.001), Social Functioning (P < 0.001), Role-Emotional (P < 0.001), and Mental Health (P < 0.001). CONCLUSIONS: BSFT effectively influenced bullying behaviour, salivary cortisol concentration, anger, and health-related QoL in adolescent bullying boys.

Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study.

OBJECTIVE: Chronic low back pain (CLBP) is a widespread ailment. The aim of this study was to assess the efficacy of topiramate in the treatment of CLBP and the changes in anger status and processing, body weight, subjective pain-related disability and health-related quality of life during the course of treatment. METHODS: We conducted a 10-week, randomized, double-blind, placebo-controlled study of topiramate in 96 (36 women) patients with CLBP. The subjects were randomly assigned to topiramate (n=48) or placebo (n=48). Primary outcome measures were changes on the McGill Pain Questionnaire, State-Trait Anger Expression Inventory, Oswestry Low Back Pain Disability Questionnaire and SF-36 Health Survey scales, and in body weight. RESULTS: In comparison with the placebo group (according to the intent-to-treat principle), significant changes on the pain rating index of McGill Pain Questionnaire (Ps<0.001), State-Trait Anger Expression Inventory Scales (all Ps<0.001), Oswestry Low Back Pain Disability Questionnaire (P<0.001), and SF-36 Health Survey scales (all P<0.001, except on the role-emotional scale) were observed after 10 weeks in the patients treated with topiramate. Weight loss was also observed and was significantly more pronounced in the group treated with topiramate than in those treated with placebo (P<0.001). Most patients tolerated topiramate relatively well but 2 patients dropped out because of side effects. DISCUSSION: Topiramate seems to be a relatively safe and effective agent in the treatment of CLBP. Significantly positive changes in pain sensitivity, anger status and processing, subjective disability, health-related quality of life, and loss of weight were observed.

Aripiprazole in the treatment of patients with borderline personality disorder: a double-blind, placebo-controlled study.

OBJECTIVE: Aripiprazole is a relatively new atypical antipsychotic agent that has been successfully employed in therapy for schizophrenia and schizoaffective disorders. A few neuroleptics have been used in therapy for patients with borderline personality disorder, which is associated with severe psychopathological symptoms. Aripiprazole, however, has not yet been tested for this disorder, and the goal of this study was to determine whether aripiprazole is effective in the treatment of several domains of symptoms of borderline personality disorder. METHOD: Subjects meeting criteria for the Structured Clinical Interview for DSM-III-R Personality Disorders for borderline personality disorder (43 women and 9 men) were randomly assigned in a 1:1 ratio to 15 mg/day of aripiprazole (N=26) or placebo (N=26) for 8 weeks. Primary outcome measures were changes in scores on the symptom checklist (SCL-90-R), the Hamilton Depression Rating Scale (HAM-D), the Hamilton Anxiety Rating Scale (HAM-A), and the State-Trait Anger Expression Inventory and were assessed weekly. Side effects and self-injury were assessed with a nonvalidated questionnaire. RESULTS: According to the intent-to-treat principle, significant changes in scores on most scales of the SCL-90-R, the HAM-D, the HAM-A, and all scales of the State-Trait Anger Expression Inventory were observed in the subjects treated with aripiprazole after 8 weeks. Self-injury occurred in the groups. The reported side effects were headache, insomnia, nausea, numbness, constipation, and anxiety. CONCLUSIONS: Aripiprazole appears to be a safe and effective agent in the treatment of patients with borderline personality disorder.

Familial and sociopsychopathological risk factors for suicide attempt in bulimic and in depressed women: prospective study.

OBJECTIVE: This study was carried out to examine sociopsychopathological predictors of prospective observed suicide attempts in bulimic women purging type without comorbid major depression (BNG) at the time of study entry and in woman with major depression without comorbid eating disorder at the time of study entry (MDG). METHODS: Data from 28 BNG (age 23.5 +/- 3.6) and 126 MDG women (age 33.4 +/- 5.1) who had attempted suicide during 12 months' monitoring were compared. RESULTS: A univariate comparison of the two groups revealed various differences. Analysis of risk factors for suicide attempts using stepwise logistic regression was conducted separately for each group. The derived logistic models showed that patients from the BNG group had a history of higher incidence of sexual abuse in childhood, as well as abuse of laxatives and illicit drugs; they also lacked orientation in life, felt lonely despite family and friends, tended to direct their anger outward, and were unable to relax. CONCLUSIONS: Sociopsychopathological risk factors for suicide attempts in the BNG and MDG appear to vary.

Topiramate treatment for women with borderline personality disorder: a double-blind, placebo-controlled study.

Borderline personality disorder is a common and severe psychiatric illness. The goal of this study was to determine whether topiramate can influence patients' borderline psychopathology, health-related quality of life, and interpersonal problems. Women meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Structured Clinical Interview II criteria for borderline personality disorder were randomly assigned in a 1:1 ratio to topiramate titrated from 25 to 200 mg/d (n = 28) or placebo (n = 28) for 10 weeks. Primary outcome measures were changes on the Symptom-Checklist, on the SF-36 Health Survey, and on the Inventory of Interpersonal Problems. Body weight and additional side effects were assessed weekly. According to the intent-to-treat principle, significant changes (all P < 0.001) on the somatization, interpersonal sensitivity, anxiety, hostility, phobic anxiety, and Global Severity Index scales of the Symptom Checklist were observed in the topiramate-treated subjects after 10 weeks (no significant changes on the obsessive-compulsive, depression, paranoid ideation, and psychoticism scales). In the SF-36 Health Survey, significant differences were observed on all 8 scales (all P < 0.01 or P < 0.001). In the Inventory of Interpersonal Problems, significant differences (all P < 0.001) were found in the scales for overly autocratic, overly competitive, overly introverted, and overly expressive (no significant differences in the scales for overly cold, overly subassertive/subservient, overly exploitable/compliant, and overly nurturant/friendly). Weight loss was additionally observed (p < 0.001). Topiramate appears to be a safe and effective agent in the treatment in women with borderline personality disorder. Additional weight loss can be expected.

Change in instrumental activities of daily living disability in female senior patients with musculosceletal pain: a prospective, randomized, controlled trial.

Previous studies found that depressive symptoms and low functional self-efficacy are associated with the occurrence of disabling musculoskeletal pain, and diminished quality of life in elderly people. The target of this study was to consider the change in instrumental activities of daily living (IADL) disability and health related quality of life after integrative psychotherapeutic treatment program of depressive symptoms in senior female patients with musculoskeletal pain. In an 8-week outpatient-based, random, prospective, controlled trial, 36 female patients between 70 and 79 with a history of clinically evident musculoskeletal pain and afflicted with depressive symptoms, but who were able to bathe, walk, dress, and transferring inside the house were evaluated. The study was performed using the Center for Epidemiological Studies Depression Scale (CES-D), IADL, and the Health Survey (SF-36). In comparison with the untreated group, according to the intent-to-treat principle, significant changes on the CES-D (P < 0.01), IADL (P < 0.01), and all scales of SF-36 were observed after eight weeks in the treated subjects. The treatment of moderate depression with integrative psychotherapy may be efficacious in improving of IADL disability and health related quality of life in affected senior female patients with musculoskeletal pain.

Mirtazapine treatment of social phobia in women: a randomized, double-blind, placebo-controlled study.

Social phobia is an anxiety disorder characterized by extreme fear and phobic avoidance of social and performance situations and by a relatively poor health-related quality of life. The goal of this study was to compare the efficacy of mirtazapine versus placebo in the treatment of patients with social phobia. In 2004, we conducted a randomized, double-blind, placebo-controlled study of mirtazapine in 66 female subjects from the general population meeting the criteria for social phobia. The subjects were randomly assigned in a 1:1 manner to mirtazapine (n = 33) or placebo (n = 33). The treatment lasted 10 weeks. Seven patients dropped out. Primary outcome measures were self-reported changes on the Social Phobia Inventory, Liebowitz Social Anxiety Scale, and Health Survey (SF-36). In comparison with the placebo group and according to the intent-to-treat principle, significant differences on the Social Phobia Inventory and Liebowitz Social Anxiety Scale scales (all P < 0.001), as well as on most (5 from 8) scales of SF-36 (all P < 0.001), were observed in the mirtazapine-treated subjects. All patients tolerated mirtazapine relatively well. Mirtazapine appears to be an effective agent in the treatment of social phobia in women and in the improvement of their health-related quality of life.

Changes in instrumental activities of daily living disability after treatment of depressive symptoms in elderly women with chronic musculoskeletal pain: a double-blind, placebo-controlled trial.

BACKGROUND AND AIMS: The purpose of this study was to assess the effect of antidepressant therapy on changes in instrumental activities of daily living disability in elderly female patients with musculoskeletal pain in a controlled study comparing active drugs with a placebo. METHODS: In an 8-week double-blind, placebo-controlled outpatient trial, 30 female patients (response rate 90.0%) between 70 and 79 were examined. They all had a history of clinically evident musculoskeletal pain, were afflicted with depressive symptoms, and could independently bathe, walk, dress, and transfer (e.g., from a chair) inside the house. The study was performed using the Center for Epidemiological Studies Depression Scale (CES-D), and Instrumental Activities of Daily Living (IADL). RESULTS: Compared with the placebo-group, significant changes in the CES-D (p<0.01) and IADL (p<0.01) scales were observed after eight weeks in the active drug-treated subjects. CONCLUSION: Treatment of depressive symptoms may be efficacious in reducing IADL disability in elderly female patients afflicted with musculoskeletal pain.

Effect of progressive muscle relaxation in adolescent female bronchial asthma patients: a randomized, double-blind, controlled study.

OBJECTIVE: The aim of this study is to examine the efficacy of progressive muscle relaxation (PMR) on change in blood pressure, lung parameters and heart rate in female adolescent asthmatics. METHOD: In a prospective, randomized, double-blind, controlled study, adolescent female asthmatics (n=31) were tested to find out how the systolic blood pressure (SBP), forced expiratory volume in the first second (FEV(1)), peak expiratory flow (PEF) and heart rate change after PMR. The control group (CG; n=30) received a placebo intervention. RESULTS: A significant reduction in SBP and a significant increase in the FEV(1) and PEF were observed after PMR. The heart rate showed a significant increase in the coefficient of variation (CV), root-mean-square of successive differences (RMSSD) and at the high frequency (HF) range, in addition to a significant reduction at the low and middle frequency (LF and MF, respectively) ranges. CONCLUSION: PMR appears to be effective in improvement of blood pressure, lung parameter and heart rate in adolescent female asthmatics.

Topiramate treatment in bulimia nervosa patients: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: The aim of the current study was to test the influence of topiramate on behavior, body weight, and health-related quality of life (HRQOL) in bulimic patients. METHOD: Thirty patients with bulimia nervosa were treated with topiramate in a 10-week randomized, double-blind, placebo-controlled study. The subjects were randomly assigned to receive topiramate (topiramate group [TG]; n = 30) or a placebo (control group [CG]; n = 30). Primary outcome measures were changes in the frequency of binging/purging, in body weight, and on the SF-36 Health Survey (SF-36) scales. RESULTS: In comparison to the CG group (according to the intent-to-treat principle), significant changes in the frequency of binging/purging (a > 50% reduction: TG, n = 11 [36.7%]; CG, n = 1 [3.3%]; p < .001), body weight (difference in weight loss between the two groups: 3.8 kg, 95% confidence interval [CI] = -5.4 to -2.1; p < .001), and SF-36 (all ps < .001) could be seen. All patients tolerated topiramate well. CONCLUSION: Topiramate appears to safe and effective in influencing the frequency of binging/purging, body weight, and HRQOL in bulimic patients.

Anger, interpersonal relationships, and health-related quality of life in bullying boys who are treated with outpatient family therapy: a randomized, prospective, controlled trial with 1 year of follow-up.

OBJECTIVE: Ten to 30% of students engage in bullying behavior. Bullies stand out on account of increased anger, poor interpersonal relationships, and poor quality of life. Our aim was to determine the effectiveness of outpatient family psychotherapy as a monotherapy for anger reduction and improvement of behavior and interpersonal relationships and of health-related quality of life in male youths with bullying behavior. METHODS: Twenty-two boys with bullying behavior took part in a family therapy program for 6 months. The control group was also composed of 22 youths and took part in a placebo intervention program. Every 2 weeks, results were checked with the Adolescents Risky-Behavior Scale (ARBS), the State-Trait Anger Expression Inventory (STAXI), the Inventory of Interpersonal Problems (IIP-D), and the SF-36 Health Survey (SF-36). Follow-up testing took place 12 months after treatment. RESULTS: In comparison with the control group (according to the intention-to-treat principle), bullying behavior was reduced (family therapy group: from n = 22 to n = 6; control group: from n = 22 to n = 20). Significant changes on all ARBS scales and on the STAXI scales State-Anger, Trait-Anger, Anger-Out, and Anger-Control were observed after 6 months. In the IIP-D, significant differences were found on the scales for overly autocratic, overly competitive, overly introverted, overly expressive, and exploitable/compliant. In the SF-36, significant differences were observed in general health perceptions, vitality, social functioning, role-emotional, and mental health. The reduction in expression of anger correlated with a reduction in several scales of the ARBS, IIP-D, and SF-36. Follow-up after 1 year showed relatively stable, lasting treatment effects. CONCLUSION: The results of this study show that outpatient family therapy seems to be an effective method of reducing anger and improving interpersonal relationships and health-related quality of life in male youths with bullying behavior.

Topiramate in treatment of depressive and anger symptoms in female depressive patients: a randomized, double-blind, placebo-controlled study.

BACKGROUND: Depression is associated with increased aggression and diminished ability and quality of life. The goal of this study was to compare the efficacy of topiramate in influencing depressive symptoms, aggression, ability, and health related quality of life in depressive women. METHODS: We conducted a randomized, double-blind, placebo-controlled 10-week study of topiramate in 64 female subjects from the general population who met criteria for recurrent major depressive disorder. Primary outcome measures were changes on the Hamilton Depression Rating Scale (HDRS), the State-Trait Anger Expression Inventory (STAXI), the Test of Attention (d2), and the SF-36 Health Survey (SF-36). RESULTS: According to the intent-to-treat principle, a significant difference on the HDRS (P=0.02), all scales of STAXI (all P<0.001), Total efficiency of d2 (P<0.001), and on most scales of SF-36 (P between 0.15 and <0.001) were observed in the topiramate-treated subjects comprised the placebo group. The reduction in expression of anger correlated significantly with changes on the HDRS, and several scales of d2 and SF-36. Additional weight loss, which was significantly more pronounced in the topiramate group than in those treated with a placebo, was ascertained (difference in weight loss between the two groups: 4.2 kg, P<0.001). All the patients tolerated topiramate relatively well. LIMITATIONS: Only moderately ill women were included. CONCLUSIONS: Topiramate appears to be an effective agent in the reduction of depressive symptoms and anger and in the improvement of ability and health-related quality of life in depressive women. Additional weight loss can be expected.

Lamotrigine treatment of aggression in female borderline-patients: a randomized, double-blind, placebo-controlled study.

Anger and aggression are typical in borderline patients. The goal of this study was to compare the efficacy of lamotrigine versus placebo in the treatment of aggression in women meeting the criteria for borderline personality disorder (BPD). We conducted a randomized, double-blind, placebo-controlled study of lamotrigine in 24 female subjects meeting Structured Clinical Interview for DSM-IV (SCID) criteria for BPD. The subjects were randomly assigned in a 2: 1 manner ratio to lamotrigine (n = 18) or placebo (n = 9). Treatment duration was 8 weeks. Primary outcome measures were self-reported changes on the anger scales of the Trait Anger Expression Inventory (STAXI). In comparison with the placebo group, and according to the intention-to-treat principle, highly significant (p < 0.01) changes on four STAXI scales (State-Anger, Trait-Anger, Anger-Out, Anger-Control) were observed in those subjects treated with lamotrigine after 8 weeks. The only exception (p < 0.05) was found on the Anger-In scale, where a difference of only 8.5% (p < 0.2) was found. All the patients tolerated lamotrigine relatively well. Lamotrigine appears to be a safe and effective agent in the treatment of anger in women with criteria-defined BPD as defined by SCID criteria. It did not produce any clinically significant effect on body weight.