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Biomedical subjects

A Kiev

Publications and source records attributed to A Kiev.

At least 19 recordsLinked to original sources
PubMed1999

Double-blind comparison of citalopram and placebo in depressed outpatients with melancholia.

This multicenter study compared the efficacy and safety of citalopram and placebo in a population of moderately to severely depressed patients with melancholia. This randomized, double-blind, parallel-group study compared citalopram (flexible dose; 20-80 mg/day) with placebo in 180 psychiatric outpatients with a DSM-III diagnosis of major depression or bipolar disorder, depressed, who also met DSM-III criteria for melancholia. Following a 1-week placebo washout period, patients meeting study entry criteria were randomized to 4 weeks of double-blind treatment with either citalopram or placebo. Efficacy measures included the Hamilton Rating Scale for Depression (HAM-D), the Clinical Global Impressions (CGI) Scale, and the Zung Self-Rating Depression Scale. Patients treated with citalopram showed significantly greater improvement at endpoint than placebo patients on the HAM-D, CGI, and Zung scales. On the HAM-D, citalopram patients exhibited significantly greater improvement than placebo patients after 1 week of double-blind treatment and at all subsequent study visits. Endpoint analyses of the HAM-D subscales demonstrated that citalopram produced significant improvement of the psychomotor retardation, cognitive disturbance, sleep disturbance, and melancholia symptom clusters. Nausea, dry mouth, somnolence, dizziness, and increased sweating were reported at higher rates by citalopram-treated patients than by placebo-treated patients, but there were no significant citalopram-placebo differences in the incidence of activation (e.g., anxiety, nervousness, insomnia) or sexual dysfunction. Analysis of electrocardiograms, vital signs, and laboratory tests did not reveal any clinically significant effects of citalopram treatment. The results of this study indicate that citalopram is safe and effective in the treatment of depressed patients with melancholia, and is associated with a favorable side effect profile and a potentially rapid onset of action.

Adult↗
PubMed1997

A double-blind comparison of fluvoxamine and paroxetine in the treatment of depressed outpatients.

BACKGROUND: Fluvoxamine and paroxetine, both serotonin selective reuptake inhibitors (SSRIs), were compared at two centers in a 7-week double-blind study in outpatients with major depression, diagnosed by DSM-III-R criteria. METHOD: Sixty patients were randomly assigned to receive dosage titrated upward to between 50-150 mg/day of fluvoxamine (N = 30) or 20-50 mg/day of paroxetine (N = 30). The mean +/- SD daily dose administered at the last assessment was 102 +/- 44 mg/day for fluvoxamine and 36 +/- 13 mg/day for paroxetine. Sixteen (53%) fluvoxamine-treated patients and 10 (33%) paroxetine-treated patients were titrated to the maximum permissible dosage of either drug. Sample size was calculated to provide at least 85% power at 5% level of significance to detect at least a 1.00-point difference in mean severity of adverse events, assuming a standard deviation of 1.0. RESULTS: Fluvoxamine and paroxetine were similarly effective in ameliorating depression as demonstrated by mean total scores of 10.9 +/- 7.3 (p < .00) and 11.5 +/- 7.4 (p < .00), respectively, in the Hamilton Rating Scale for Depression (HAM-D). Adverse events were mostly mild to moderate in severity. The most common events were headache (N = 17, 57%), nausea (N = 14, 47%), sweating (N = 10, 33%), somnolence (N = 9, 30%), diarrhea (N = 9, 30%), dry mouth (N = 8, 27%), dizziness (N = 8, 27%), and, among males, impotence (N = 3, 21%) and ejaculatory abnormality (N = 3, 21%) in the paroxetine group, and headache (N = 12, 40%), somnolence (N = 12, 40%), nausea (N = 11, 37%), dry mouth (N = 11, 37%), insomnia (N = 9, 30%), asthenia (N = 7, 23%), and dyspepsia (N = 7, 23%) in the fluvoxamine group. The only statistically significant difference between treatment groups was for sweating (33% paroxetine vs. 10% fluvoxamine, p = .028). CONCLUSION: Observed differences in some side effects, although not statistically significant, indicate that when a patient has difficulty tolerating one SSRI, the clinician may choose to change to a different agent within the same class.

Adolescent↗
PubMed1997

Management of clinical trials with new medications for cocaine dependence and abuse.

Clinical trials require a quite distinct shift in attitudes and procedures from ordinary clinical practice insofar as they require a proactive approach to patient recruitment, enrollment, and followthrough as well as significant attention paid to issues of documentation, regulatory compliance, and error prevention. Take documentation, for example: Today's requirement to have an independent record of clinical events that are recorded on the case report forms was until 5 or 7 years ago not addressed in as much detail as it is today. This is one of the first adjustments that the new investigator must address. The researcher must keep looking to see what is missing from the location and procedures as a study takes place in order to create the necessary patient base for doing the study and ensuring that all needs necessary to produce the result are in place and that procedures are done with as few errors as possible. Everything must be done in conformance with good clinical practice and the standards set by the protocol. The researcher must be willing to deal with a world of breakdowns such as missing data, and the failure of the patient to revisit the office within the appropriate time dictated by the protocol and within the window of time or grace period allowed by the study. The researcher must ensure that the patients comply with the dosing schedule and that they are trained to return medications for accurate pill counts. And so on. This means creating new procedures that are motivated by a commitment to producing a specific enrollment result defined by specific criteria and increasingly because of the press of time enrolled in a specific time period and put through a well-defined protocol process. Clinical research is dependent on a willingness to commit to a specific end result and do all that is necessary on a day-by-day basis to produce that result in terms of specific numbers, clean and accurate case report forms that are backed up by corroborating source documents in line with a specific timeline in which to accomplish the task, and an outreach effort to recruit and enlist patients, which may involve advertising and promotion of the program, all of which may contrast significantly with customary practice. Clinical research involves reliance on additional dedicated personnel who are critical parts of the research team, including the telephone screening person who must be trained to follow a script and at the same time to be aware of the nuances of enrolling appropriate and compliant patients. The entire staff must be made part of the process and must work in concert to recruit and maintain the patient in a study while being aware of the effect these efforts may have on the placebo effect. It also requires considerable training, review, and constant communication among the staff to ensure that the complex coordination of numerous patients and procedures works smoothly. There needs to be a willingness among the staff and the investigators to take correction from monitors who visit the site periodically and whose focus is on the quality of the data and not so much on the qualifications of the staff. This is not an action that people in nonresearch environments are trained to take. Failure to appreciate the complexity of conducting clinical trials can contribute to much frustration to everyone involved. When there is understanding of all the variables that influence the ultimate results, there is a willingness to anticipate breakdowns and to turn breakdowns into opportunities to create new structures and develop new procedures that will ultimately facilitate a successful outcome.

Clinical Trials as Topic↗
PubMed1996

Nefazodone versus sertraline in outpatients with major depression: focus on efficacy, tolerability, and effects on sexual function and satisfaction.

BACKGROUND: The efficacy, tolerability, and effects on sexual function and satisfaction of nefazodone and sertraline were compared in a multicenter, randomized, double-blind, parallel-group study in outpatients with major depression. METHOD: One hundred sixty patients, 18 years of age or older, who met DSM-III-R criteria for single or recurrent nonpsychotic major depressive episodes were randomly assigned to 6 weeks of treatment with either nefazodone (100-600 mg/day) or sertraline (50-200 mg/day). Symptoms were assessed before and during treatment using the 17-item Hamilton Rating Scale for Depression (HAM-D-17), Clinical Global Impressions (CGI) Improvement scale, the CGI Severity of Illness scale, and a sexual function questionnaire. RESULTS: Of 143 patients evaluable for efficacy, 72 received sertraline and 71 received nefazodone. The mean modal daily dose at endpoint was 148 mg for sertraline and 456 mg for nefazodone. Analysis of efficacy measures (HAM-D-17 and CGI) showed consistent and comparable improvement in symptoms of depression for both treatment groups. Sertraline had negative effects on sexual function and satisfaction in both men and women, and nefazodone had no adverse effect on sexual well-being. Safety assessments based on adverse events, vital sign measurements, electrocardiographs, physical examinations, and clinical laboratory tests revealed no serious adverse events or organ toxicity associated with nefazodone or sertraline administration. CONCLUSION: Nefazodone and sertraline are well tolerated, and there was no statistically significant difference in their antidepressant activity. Sertraline treatment has negative effects on sexual function and performance in both sexes, while nefazodone has none. These findings may have clinical implications when choosing antidepressant therapy.

1-Naphthylamine↗
PubMed1994

The cardiovascular effects of bupropion and nortriptyline in depressed outpatients.

The cardiovascular effects of bupropion hydrochloride and nortriptyline were compared in a double-blind, randomized, 6-week trial in adult outpatients with major depression. After a 1-week placebo phase, 58 patients were randomized to treatment with bupropion (225-450 mg/day) and 57 to nortriptyline (75-150 mg/day). Nortriptyline-treated patients had statistically significant heart rate increases at each assessment as determined by RR intervals on electrocardiogram (14.5-18 bpm). Bupropion-treated patients had small but statistically significant increases in supine diastolic blood pressure of 5.6 mm Hg on day 7 and 7.5 mm Hg on day 28. A few patients in each treatment group had orthostatic changes, but only nortriptyline-treated patients had symptomatic orthostatic hypotension. A slowing of cardiac conduction and possibly of rate-corrected repolarization occurred in patients treated with nortriptyline that did not occur in patients treated with bupropion. Compared to nortriptyline, bupropion appears to have a wider safety margin with regard to cardiovascular effects. This may be particularly true in the elderly, in patients with preexisting cardiovascular disease, or in overdose.

Adult↗
PubMed1994

Long-term safety and clinical acceptability of venlafaxine and imipramine in outpatients with major depression.

The antidepressant efficacy and safety of venlafaxine was shown previously in 6-week, placebo-controlled trials. We evaluated the long-term safety and clinical acceptability of venlafaxine and imipramine in a double-blind, parallel-group, comparative study. Two hundred ninety depressed outpatients were treated with venlafaxine, and an additional 91 received imipramine for as long as clinically necessary, up to 1 year. The total daily dose of each drug could vary from 75 to 225 mg. The Clinical Global Impressions Scale and a therapeutic response rate that was based on Clinical Global Impressions Scale-Improvement and incorporated discontinuation information were used to evaluate efficacy. Safety determinations and patient subjective ratings were used to evaluate safety and clinical acceptability. During the study, the adverse events were generally mild to moderate and most subsided with continued treatment; the most frequent were nausea for venlafaxine and dry mouth for imipramine. The anticholinergic side effect burden was significantly higher in the imipramine group than in the venlafaxine group. Venlafaxine was judged significantly more acceptable than imipramine, on the basis of the subjective ratings by patients. Fewer venlafaxine-treated patients than imipramine-treated patients withdrew because of adverse events and unsatisfactory response. There was a consistent trend in the therapeutic response rates in favor of venlafaxine that reached statistical significance at months 2, 6, and 12. In this long-term study, patient acceptability was greater for venlafaxine than for imipramine, suggesting therapeutic advantages for venlafaxine in the long-term treatment of depression. Additional studies with other active comparators are underway to confirm and extend these encouraging results.

Adult↗
PubMed1993

A comparison of paroxetine and placebo in depressed outpatients.

To compare the safety and efficacy of paroxetine (n = 167) and placebo (n = 169), data from 4 centres using the same protocol were pooled. A double-blind parallel group design was used, with therapy lasting 6 weeks. Significant differences between paroxetine- and placebo-treated patients were found on the major efficacy outcome variables by week 2 and on all efficacy variables by week 4 of the study. Improvement on the sleep factor of the Hamilton Rating Scale for Depression was found after 7 d. Observer and patient global efficacy ratings were in agreement by week 4. No serious adverse events occurred, and paroxetine had no clinically significant effects on vital signs or laboratory safety data. Side effects were more common on paroxetine and were similar to other serotonin reuptake inhibitors. In general, these were well tolerated and did not lead to dropout. Symptoms of increased arousal were not seen during early therapy.

Adolescent↗
PubMed1992

Paroxetine versus placebo: a double-blind comparison in depressed patients.

BACKGROUND: Paroxetine is a potent and selective serotonin reuptake inhibitor (SSRI). The present study assessed the efficacy and tolerability of paroxetine against placebo in depressed outpatients. METHOD: A double-blind, parallel-group study was undertaken in four stand-alone centers. Patients aged 18-65 years, meeting DSM-III criteria for major depression, and having a Hamilton Rating Scale for Depression (HAM-D) score > or = 18 on the first 17 items of the HAM-D-21 were randomized to paroxetine or placebo for 6 weeks of treatment. Efficacy outcome variables included the HAM-D, the Montgomery-Asberg Depression Rating Scale, the Clinical Global Impressions Scale (CGI), and the Covi Anxiety Scale. Tolerability was assessed by asking a non-leading question. Routine laboratory safety and vital sign data from all four centers were pooled. The primary analysis used the intention-to-treat sample and for efficacy variables the last-observation-carried-forward data set was employed. Statistical methods included one-way analysis of variance for parametric and Fisher exact test for nonparametric variables. RESULTS: Significant differences (p < or = .05) were found between paroxetine and placebo on the HAM-D and CGI by Week 2 and on all efficacy outcome variables by Week 4. Improvement on the HAM-D sleep factor occurred 2 weeks prior to that seen on the retardation factor. Similar results were obtained when an adequate treatment group (therapy for > or = 28 days) was considered. A full clinical response (CGI-severity of illness score 1 or 2) was seen in over 40% of subjects. Adverse events were more common for paroxetine compared with placebo (p < or = .01). Somnolence was twice more common than nervousness. Dropout due to adverse events was similar between therapies. Paroxetine had no clinically significant effect on laboratory safety data or vital signs. CONCLUSION: Paroxetine was an effective, well tolerated, and safe antidepressant. Side effects were typical of the SSRI class of drugs. Symptoms indicative of a nonalerting profile were more common than those associated with alerting effects.

Adolescent↗
PubMed1992

A double-blind, placebo-controlled study of paroxetine in depressed outpatients.

Paroxetine is an investigational antidepressant that acts through selective inhibition of serotonin reuptake at the synapse. In this study, 81 outpatients with major depression according to DSM-III criteria were treated with either paroxetine or placebo in a 6-week, randomized, double-blind study. Paroxetine was significantly superior to placebo on all major efficacy variables, including depression as well as anxiety, cognitive disturbance, insomnia, psychomotor retardation, and sleep disturbance. Significant differences in favor of paroxetine were apparent by Week 2. Paroxetine was also well tolerated. The results support the efficacy and safety of paroxetine as a treatment for patients with major depression.

Ambulatory Care↗
PubMed1989

Double-blind, placebo-controlled, fixed dose trial of minaprine in patients with major depression.

Minaprine dihydrochloride is a novel psychotropic drug possessing both antidepressant and psycho-stimulant properties. Prior clinical studies have shown minaprine to be as effective as standard antidepressant agents in the treatment of endogenous depression. The present study examined the safety and efficacy of minaprine at four different doses compared to placebo in 190 outpatients with major depression. Overall, minaprine demonstrated a significant antidepressant action compared to placebo, which was most evident at the maximum dose of 400 mg daily. These data, together with a favorable side effects profile, suggest that minaprine may be an effective antidepressant agent for the treatment of major depression.

Adult↗
PubMed1988

A study of buspirone coprescribed with bronchodilators in 82 anxious ambulatory patients.

This was an open multicenter study wherein patients requiring anxiolytic therapy were treated with buspirone 5 mg t.i.d. for 4 weeks. A subgroup of 82 patients was concomitantly treated with bronchodilators. Theophylline and terbutaline were the most frequently used preparations. A matching cohort of 82 patients who used no concomitant bronchodilators was retrospectively selected as the control. Both groups of patients showed substantial and comparable improvement as measured by the physician and patient ratings. The bronchodilator group had an incidence of adverse effects (16%) slightly higher than that of the control group (12%), due mainly to a higher incidence of dizziness (8.5% versus 2.4%). The results indicate that buspirone is effective and well tolerated when taken in combination with a wide variety of bronchodilator medications.

Ambulatory Care↗
PubMed1979

A placebo-controlled multicenter trial of Limbitrol versus its components (amitriptyline and chlordiazepoxide) in the symptomatic treatment of depressive illness.

In a multicenter, placebo-controlled, clinical trial, the efficacy of Limbitrol was compared with that of its components, amitriptyline and chlordiazepoxide. All patients had a diagnosis of primary depression. Data from 279 patients were evaluated using the Hamilton depression scale, the Beck depression inventory, and physician and patient global change measures. Statistically significant differences favoring Limbitrol occurred after 1 week of treatment, and a trend in favor of Limbitrol continued throughout the remaining 3 weeks. In most efficacy comparisons, the combination was as good as, or better than, amitriptyline alone. It was superior to chlordiazepoxide alone after 2 and 4 weeks of treatment. Each component produced an independent contribution to the total therapeutic effect: the chlordiazepoxide effect was more prominent in the first 2 weeks and the amitriptyline effect in the latter 2 weeks. A trend favoring amitriptyline over chlordiazepoxide was evident by week 4. The overall incidence of side effects was comparable in both Limbitrol- and amitriptyline-treated groups. Limbitrol-treated patients exhibited more sedation, but significantly fewer Limbitrol patients discontinued treatment prematurely because of side effects.

Adult↗
PubMed1976

Cluster analysis profiles of suicide attempters.

The author reports the results of a three-stage cluster analysis of data on 298 patients who attempted suicide. Patients were allocated by the analysis to seven identifiable profile types that correlated with six outcome variables. These profiles include data on the social setting and the seriousness of the attempt and judgments about overall functioning and interpersonal conflict as well as the input of the patients' significant others. The author states that these profiles have prognostic significance as well as implications for the treatment of suicide attempters and the education of emotionally involved significant others.

Anxiety↗
PubMed1976

Cultural perspectives on the range of human behavior.

Traditional societies provide a homogeneous world view for everyone, encouraging people to work towards specific objectives. Lack of flexibility in the culturally defined ways of reaching these objectives creates considerable distress for individuals. In rapidly changing urban settings, unlimited modalities create the anxieties which in turn lead people to search for security in unsuitable patterns of belief and behavior. Others tolerate uncertainty better if the culture assisted them in developing skills for becoming involved in short term immediate objectives without having to mortgage the present for a vague future. In our own society recent reorientation towards a traditional type fatalism and a de-emphasis on the Puritan work ethic reflects a marked value shift which may stultify many, much as it fosters increased individualization among others.

Adaptation, Psychological↗
PubMed1975

Psychotherapeutic strategies in the management of depressed and suicidal patients.

This paper examines the Crisis Intervention Therapy developed by Dr. Kiev's Cornell Program, for the management of depressed and suicidal patients. Combining chemotherapy with supportive psychotherapy, he emphasizes the acquisition of Life Strategy Skills, using motivational audiotaped material. The therapeutic rationale is also explored and related to the explosive and unpredictable interpersonal world of suicidal patients and attiudes of patients and significant others toward the sick role.

Adaptation, Psychological↗