APA Meeting Highlights New Research

Partial Hospitalization and Weight Gain in Anorexia Nervosa Patients

Because there is intense pressure by managed care to shorten the hospital stay for patients with anorexia nervosa, there is a need for partial-hospitalization treatment programs. Since patients gain an average of 0.5 lbs/week to 1.5 lbs/week in these less-monitored programs, as opposed to 2 lbs/week to 3 lbs/week in the inpatient behavioral specialty programs, Angela S. Guarda, M.D., and colleagues (Symposium 21B) described components that would improve the partial treatment program.

In order for a partial-hospitalization program to be successful, the researchers found, it must have the following components: 1) a step-down, seamless inpatient-partial-hospitalization model of care; 2) flexibility in rapidly titrating percent of supervised meals to progress with weight gain; and 3) behavioral focus on practicing healthy eating behaviors. While a partial-hospitalization program with these components may not have the same rapid weight gain results of the inpatient treatment programs, it may still be effective in treating anorexia nervosa.

Because few studies have evaluated the use of antipsychotics among juveniles with bipolar disorder, an eight-week, open-label study was conducted by Jean A. Frazier, M.D., et al. (New Research 482) to assess the safety and efficacy of olanzapine(Drug information on olanzapine) (Zyprexa) in this population. Bipolar disorder patients ages 5 to 14 (n=23) received olanzapine (2.5 mg/day to 20 mg/day). The Young Mania Rating Scale (YMRS) was used as the primary outcome measure.

Results show that olanzapine was a safe and effective monotherapy for juvenile bipolar disorder. Weight gain was the only adverse side effect. Additional controlled studies are needed to confirm these results.

Paul J. Perry, M.D., et al. (New Research 568) conducted a randomized, double-blind, parallel study to determine an efficacious treatment of adult attention-deficit/hyperactivity disorder (ADHD). Following a seven-day placebo lead-in, 29 ADHD patients (18 to 60 years old) were randomized to bupropion (Wellbutrin) sustained release (SR), methylphenidate (Ritalin) or placebo for eight weeks. Methylphenidate was titrated over one week to a maximum dose of 0.9 mg/kg (divided into three doses), while bupropion was titrated over two weeks to a maximum dose of 200 mg in the morning and 100 mg in the evening.

According to the Clinical Global Impression (CGI) scale ratings, much improvement was noted in 64% of the bupropion SR-treated patients and 50% of methylphenidate-treated patients. Of the placebo-treated patients, 30% experienced insignificant improvements, according to the Fisher Exact Test. These findings suggested that bupropion SR may be beneficial as a treatment for adult ADHD.

This study by Ruta M. Nonacs, M.D., et al. (New Research 694) assessed the impact of treatment with typical or atypical neuroleptic medications on female menstrual and sexual functioning. The 30 female patients in this study were treated with either risperidone(Drug information on risperidone) (Risperdal) (dosage range 2.5 mg/day to 3 mg/day), olanzapine (5 mg/day to 25 mg/day) or a typical neuroleptic. For four months, data regarding their menstrual cycles, sexual functioning and hormone levels were collected.

The results showed that menstrual irregularities occurred in 33.3% of women on risperidone and 16.7% of women on traditional antipsychotic medication. Women on olanzapine did not experience irregularity. These findings showed that menstrual irregularities are commonly associated with high prolactin levels and frequently occur in women treated with risperidone. Further study is needed to determine the extent to which these changes in menstrual function reflect risk for end organ sequelae.

Haloperidol (Haldol) therapy in the treatment of Tourette's syndrome (TS) has limitations because of extrapyramidal side effects (EPS). Since therapeutic doses of risperidone are not usually associated with these side effects, a study was conducted to see if risperidone was effective in reducing or eliminating the tics associated with TS, while maintaining a more favorable safety profile than haloperidol(Drug information on haloperidol).

Yves Dion, M.D., and colleagues (New Research 695) conducted a randomized, double-blind, placebo-controlled, eight-week trial using 48 patients with TS. Twenty-four patients were assigned to placebo and 24 to treatment with risperidone doses of 0.5 mg/day to 6.0 mg/day. Patients were assessed at baseline and during treatment on the Tourette's Syndrome Severity Scale (TSSS), CGI, Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Extrapyramidal Symptoms Rating Scale (ESRS) and Global Assessment of Functioning (GAF) scale.

Researchers concluded that risperidone at a median dose of 2.5 mg/day (range 1 mg/day to 6 mg/day) may be an effective and well-tolerated treatment for tics in patients with TS. Of the risperidone-treated patients, 60.8% improved by at least one point on the TSSS severity scale compared with only 26.1% in the placebo-treated group. Only infrequent and mild EPS occurred with risperidone.

A randomized, double-blind study was conducted by Paul E. Keck Jr., M.D., and Kathleen Ice, Ph.D. (New Research 224), to compare flexible-dose oral ziprasidone (Zeldox) 80 mg/day to 160 mg/day (n=131) with placebo (n=64) over three weeks in inpatients with acute mania. Bipolar patients with acute mania who provided written informed consent and had a baseline Schedule for Affective Disorders and Schizophrenia-Change (SADS-C) Mania Rating Scale (MRS) score 14 were assessed using the SADS-C, Positive and Negative Syndrome Scale (PANSS), and CGI-Severity of Illness (CGI-S), Simpson-Angus, Barnes Akathisia and AIMS scales. More improvements in the MRS score were observed with ziprasidone than with placebo at all time points beginning on day 2.

The results of the study indicate that ziprasidone was well-tolerated and appears to offer a rapidly effective treatment for patients with bipolar mania.

To treat the onset of sexual side effects from selective serotonin reuptake inhibitors, 24 patients were given bupropion SR with escalating doses up to 300 mg/day for seven weeks after being euthymic for at least two weeks.

When prescribed in an open fashion, as in this study by Michael J. Gitlin, M.D., and colleagues (New Research 617) bupropion SR was found to be effective in treating all the major sexual side effects of SSRIs. In fact, positive effects were seen early (within the first two weeks) and at low doses. All sexual side effects improved in response to bupropion, with men and women showing equal signs of improvement for each side effect.

The answer to this query is "yes," according to the results of a double-blind, placebo-controlled, four-week study by Peter D. Feldman, Ph.D., et al. (New Research 481). Compared to placebo, olanzapine demonstrated superior efficacy and a favorable safety profile in the treatment of acute mania and depressive symptoms. In this study, patients with a diagnosis of bipolar I disorder, manic or mixed, with or without psychotic features, were randomized to receive a dose range of 5 mg/day, 10 mg/day, 15 mg/day or 20 mg/day of either olanzapine (n=55) or placebo (n=60). Assessment measures included the YMRS, the 21-question Hamilton Rating Scale for Depression (HAM-D-21) and the CGI-S scales.

Olanzapine was generally well-tolerated; only two olanzapine-treated patients discontinued dosage due to adverse events (unintended pregnancy and rash). Somnolence was the only adverse condition that occurred significantly more often in olanzapine-treated patients. There were no significant differences on measures of parkinsonism or akathisia between olanzapine- and placebo-treated patients.

Researchers sought to determine the following: a) whether pretreatment anxiety levels in patients with major depressive disorder (MDD) were associated with preferential antidepressant response to either bupropion SR or sertraline (Zoloft) and b) whether or not these drugs caused a reduction in anxiety symptoms.

A. John Rush, M.D., and colleagues (New Research 508) conducted a post hoc analysis on a 16-week, randomized, double-blind study comparing bupropion SR (n=122) and sertraline (n=126) in outpatients with MDD. Antidepressant response and clinically significant anxiolysis were defined by 50% reduction in symptoms of anxiety and depression.

Bupropion SR and sertraline showed comparable antidepressant and anxiolytic activity. Therefore, choosing antidepressants based on levels of baseline anxiety or on anticipation of more rapid anxio-lysis is unreliable.

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