A Double Blind Trial of Moclobemide versus Amltrlptyllne in the Treatment of Depressive Disorders

1990 ◽  
Vol 24 (4) ◽  
pp. 475-479 ◽  
Author(s):  
Gil M. Newburn ◽  
Allen R. Fraser ◽  
David B. Menkes ◽  
Paul E. Mullen
Keyword(s):  
Postural Hypotension ◽  
Time Course ◽  
Depressive Disorders ◽  
Monoamine Oxidase Inhibitor ◽  
Oxidase Inhibitor ◽  
Side Effect Profile ◽  
Double Blind Trial ◽  
Double Blind ◽  
Antidepressant Efficacy ◽  
To Receive

The antidepressant efficacy and side-effect profile of amitriptyline were compared to those of moclobemide, a reversible monoamine oxidase inhibitor with selectivity for the type A isozyme. Forty nine patients with DSM-Ill major depression were randomly assigned to receive either amitriptyline or moclobemide. Thirty seven patients (amitriptyline n=l6, moclobemide n=21) completed the six week protocol, which was conducted under double blind conditions. The results indicated a comparable antidepressant time course and efficacy for the two treatments. Amitriptyline produced significantly more sedation and antimuscarinic side-eff ects. Moclobemide appears to be a well tolerated antidepressant without the liability to produce significant postural hypotension and without the need for a tyramine-poor diet.

A Multicentre Double Blind Trial of Fluoxetine versus Amitriptyline in the Treatment of Depressive Illness

1993 ◽  
Vol 27 (1) ◽  
pp. 49-55 ◽  
Author(s):  
Fiona K. Judd ◽  
Kate Moore ◽  
Trevor R. Norman ◽  
Graham D. Burrows ◽  
Ramesh K. Gupta ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Serotonin Reuptake ◽  
Depressive Illness ◽  
Fixed Dose ◽  
Side Effect Profile ◽  
Double Blind Trial ◽  
Double Blind ◽  
Antidepressant Efficacy ◽  
To Receive

The antidepressant efficacy and side effect profile of a fixed dose of 20 mg/day of fluoxetine, a specific serotonin reuptake inhibitor, were compared to those of amitriptyline. Fifty-eight patients with DSM-III-R depression were randomly assigned to receive either fluoxetine or amitriptyline. Fifty-six patients (fluoxetine N = 23, amitriptyline N = 23) completed the 6 week study. Comparable antidepressant efficacy was demonstrated for the two drugs. Patients taking fluoxetine reported less side-effects than those taking amitriptyline.

The Efficacy of Electroconvulsive Therapy in the Treatment of Schizophrenia

1987 ◽  
Vol 151 (2) ◽  
pp. 152-155 ◽  
Author(s):  
K. R. Abraham ◽  
P. Kulhara
Keyword(s):  
Electroconvulsive Therapy ◽  
Rating Scale ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
Brief Psychiatric Rating Scale ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale ◽  
To Receive

The efficacy of ECT was investigated in a double-blind trial. Twenty-two patients with schizophrenia received trifluoperazine and were randomly allocated to receive eight real or eight simulated ECTs. In the first eight weeks, the group receiving real ECTs showed significantly more improvement as measured on the Brief Psychiatric Rating Scale. However, the groups showed no significant differences from the twelfth week onwards. The superiority of real ECT was not confirmed at the end of six months.

Influence of Warfarin on Symptoms of Fatigue: Findings of a Randomized Trial

2005 ◽  
Vol 39 (5) ◽  
pp. 840-842 ◽  
Author(s):  
Michael J Kovacs ◽  
Clive Kearon ◽  
Jim A Julian ◽  
James D Douketis ◽  
Christine Demers ◽  
...  
Keyword(s):  
Risk Factor ◽  
Venous Thromboembolism ◽  
Warfarin Therapy ◽  
Study Drug ◽  
Global Rating ◽  
Double Blind Trial ◽  
Short Term ◽  
Open Label ◽  
Double Blind ◽  
To Receive

BACKGROUND: Some patients develop fatigue while taking warfarin, but causality is uncertain. OBJECTIVE: To assess whether warfarin use is associated with fatigue. METHODS: This investigation was a substudy of a randomized double-blind trial in 13 outpatient thromboembolism clinics. Subjects who had received one month of open-label warfarin therapy for venous thromboembolism due to a transient risk factor were randomly assigned to receive warfarin or placebo for 2 months and followed for another 9 months after stopping the study drug. Fatigue was measured using a Likert scale, and change of fatigue was measured by the patient's global rating. RESULTS: In 87 subjects, the overall ratings of fatigue were 0.1 unit lower (95% CI 0.6 units lower to 0.4 units higher) while taking warfarin. Global rating for change in fatigue intensity showed no increase of fatigue with warfarin use. CONCLUSIONS: The short-term use of warfarin was not associated with symptoms of fatigue.

Randomized Double-Blind Trial of Prophylactic Oral Minocycline and Topical Tazarotene for Cetuximab-Associated Acne-Like Eruption

2007 ◽  
Vol 25 (34) ◽  
pp. 5390-5396 ◽  
Author(s):  
Alon Scope ◽  
Anna Liza C. Agero ◽  
Stephen W. Dusza ◽  
Patricia L. Myskowski ◽  
Jocelyn A. Lieb ◽  
...  
Keyword(s):  
Lower Proportion ◽  
Double Blind Trial ◽  
Double Blind ◽  
Acneiform Rash ◽  
The Face ◽  
Grade 3 ◽  
Colorectal Cancer Patients ◽  
To Receive ◽  
Severe Rash ◽  
Cetuximab Therapy

Purpose To evaluate the ability of either oral minocycline, topical tazarotene or both, to reduce or prevent cetuximab-related acneiform rash when administered starting on day 1 of cetuximab therapy. Patients and Methods Metastatic colorectal cancer patients preparing to initiate cetuximab were randomly assigned to receive daily oral minocycline or placebo, and to receive topical tazarotene application to either left or right side of the face. Both therapies were administered for 8 weeks. Results Forty-eight eligible patients were randomly assigned to minocycline (n = 24) or placebo (n = 24). Total facial lesion counts were significantly lower in patients receiving minocycline at weeks 1 through 4. At week 4, a lower proportion of patients in the minocycline arm reported moderate to severe itch than in the placebo arm (20% v 50%, P = .05). Facial photographs, obtained at week 4, were reviewed for rash global severity. Patients in the minocycline arm trended toward lower frequency of moderate to severe rash than patients receiving placebo (20% v 42%, P = .13). The differences in total facial lesion counts and subjectively assessed itch were diminished by week 8. Cetuximab treatment was interrupted because of grade 3 skin rash in four patients in the placebo arm, and none in the minocycline arm. There was no observed clinical benefit to tazarotene application. Tazarotene treatment was associated with significant irritation, causing its discontinuation in one third of patients. Conclusion Prophylaxis with oral minocycline may be useful in decreasing the severity of the acneiform rash during the first month of cetuximab treatment. Topical tazarotene is not recommended for management of cetuximab-related rash.

Does biomarker information impact patients’ preferences for therapy?

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6527-6527
Author(s):  
Ann H. Partridge ◽  
Karen Sepucha ◽  
Anne O'Neill ◽  
Kathy Miller ◽  
Emily Baker ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Preference ◽  
Treatment Preferences ◽  
Double Blind Trial ◽  
Double Blind ◽  
Increased Risk ◽  
The Impact ◽  
To Receive

6527 Background: Biomarker information can risk stratify patients based on potential for benefits/toxicity from therapy. Ideally, a biomarker will identify those who benefit with limited toxicity. However, the impact of biomarkers is unclear when indicting individuals with greatest benefit are also at increased risk for toxicity. Methods: We surveyed participants at 18 month follow-up in the Decision-Making/Quality of Life (DM-QOL) component of ECOG5103, a RCT where patients were randomized to receive adjuvant chemotherapy for breast cancer with either placebo or bevacizumab (in 2 schedules). We asked patients for the preferred treatment in two hypothetical scenarios: 1) preference for chemo A or chemo A + B without biomarker information; 2) preference for chemo A or chemo A+B when participants tested positive for a “B-receptor” which increased both the benefit and toxicity of chemo A+B. McNemar’s test was used to examine changes in preferences. Results: 439 patients completed both scenarios on 18-month survey. The Table shows the treatment preferences in each scenario. The positive biomarker information in scenario 2 led 60/439 (14%) participants to switch their preference. The main reason for treatment preference in scenario 2 was greater benefits of chemo A+B (64%), the lower risks with chemo A (20%) and positive biomarker (10%). Among participants who changed preference, those randomized to receive bevacizumab were more likely to switch to chemo A in scenario 2. Conclusions: Information about a positive biomarker, indicating increased benefit and increased risk from additional chemo, did not significantly change participants’ preferred treatment. All participants were involved in a large placebo controlled double blind trial and the majority (70%) preferred the most aggressive course of treatment in both scenarios. Whether patients not enrolled in the trial would be more sensitive to the increased risk information is unclear. [Table: see text]

A phase I pharmacokinetics trial comparing PF-05280014 (a potential biosimilar) and trastuzumab in healthy volunteers (REFLECTIONS B327-01).

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 171-171 ◽  
Author(s):  
Donghua Yin ◽  
Kerry B. Barker ◽  
Ruifeng Li ◽  
Xu Meng ◽  
Steven D. Reich ◽  
...  
Keyword(s):  
Double Blind Trial ◽  
Healthy Male ◽  
Double Blind ◽  
Treatment Interruptions ◽  
The Us ◽  
Identical Amino Acid Sequence ◽  
To Receive ◽  
Clinical Trial Information ◽  
Time Point

171 Background: PF-05280014, a proposed biosimilar to trastuzumab, has an identical amino acid sequence and similar physicochemical and in vitro functional properties to trastuzumab. This study was designed to demonstrate PK similarity of PF-05280014 to trastuzumab from the US (trastuzumab-US) and EU (trastuzumab-EU), and between the licensed drugs. Safety and immunogenicity were also evaluated. Methods: In this double-blind trial (NCT01603264), 105 healthy male volunteers, 18-55 years old were randomized 1:1:1 to receive a single 6 mg/kg IV dose of PF-05280014, trastuzumab-US or trastuzumab-EU. All subjects provided informed consent. PK, safety and immunogenicity assessments were conducted for 70 days. PK similarity for a given test-to-reference comparison was considered to be demonstrated if the 90% CI of the test-to-reference ratio of the AUC from time 0 to the last time point (AUCT) and maximum concentration (Cmax) were within 80% – 125%. Results: The baseline demographics for the 101 subjects evaluable for PK were similar among 3 treatment arms. The 3 study drugs exhibited similar characteristics of target-mediated disposition and similar PK parameters (Table). The 90% CI for the ratios of Cmax, AUCT, and AUC0-∞were within 80% – 125% for the comparisons of PF-05280014 to trastuzumab-EU or trastuzumab-US, and trastuzumab-EU to trastuzumab-US. Adverse events (AE) were similar for the 3 arms with treatment-related AEs reported by 71.4%, 68.6%, and 65.7% subjects in the PF-05280014, trastuzumab-EU and trastuzumab-US, respectively. No serious AEs were reported. Only 4 subjects had treatment interruptions; 2 discontinued. Only 1 subject (trastuzumab-EU) developed anti-drug antibodies after dosing. Conclusions: This study demonstrates PK similarity of PF-05280014 to both trastuzumab-US and trastuzumab-EU and of trastuzumab-EU to trastuzumab-US. The 3 study drugs also showed similar safety profiles. Clinical trial information: NCT01603264. [Table: see text]

Administration of a gonadotropin releasing hormone analogue in oligozoospermic infertile males

1988 ◽  
Vol 117 (2) ◽  
pp. 265-267 ◽  
Author(s):  
D. F. Badenoch ◽  
Jonathan Waxman ◽  
L. Boorman ◽  
B. Sidhu ◽  
H. D. Moore ◽  
...  
Keyword(s):  
Inhibitory Effect ◽  
Gonadotropin Releasing Hormone ◽  
Double Blind Trial ◽  
Serum Concentrations ◽  
Hormone Analogue ◽  
Double Blind ◽  
Releasing Hormone ◽  
Blind Trial ◽  
Gonadotropin Releasing Hormone Analogue ◽  
To Receive

Abstract. This study investigated the stimulatory potential of a superactive gonadotropin releasing hormone analogue in idiopathic oligozoospermia. In a double-blind trial, 19 men were randomized to receive buserelin (D-Ser(TBU)6-GnRH ethylamide) in one of two dosages or saline, twice weekly, for twelve weeks. Treatment did not lead to a significant increase in serum concentrations of the pituitary gonadotropins or in sperm concentrations. However, in the dosages and schedules investigated, there was no inhibitory effect of the analogue. Further assessment of this approach is suggested.

Withdrawal of Long-Term Phenothiazines from Chronically Hospitalized Psychiatric Patients

1964 ◽  
Vol 9 (4) ◽  
pp. 290-298 ◽  
Author(s):  
G. Marjerrison ◽  
D. Irvine ◽  
C. N. Stewart ◽  
R. Williams ◽  
H. Matheu ◽  
...  
Keyword(s):  
Urinary Excretion ◽  
Time Course ◽  
Psychiatric Patients ◽  
Behavioural Change ◽  
Control Group ◽  
Double Blind ◽  
Single Measure ◽  
Double Blind Design ◽  
To Receive

A study was conducted of the effect of substituting placebo medication for active phenothiazine medication under double-blind conditions, in a population of chronically hospitalized psychotic patients who had all been undergoing long-term phenothiazine treatment. Behavioural change was assessed monthly by psychiatric nurses using a ward behaviour inventory, which had been specially constructed to be sensitive to kinds of behaviour likely to affect the clinical prescription of phenothiazines. At the fifth month of the study, differences were noted between the placebo-substituted group and a control group continuing to receive their originally-prescribed phenothiazine compounds. Significant worsening in the Placebo group did not appear until the fifth monthly rating, and at that time significant improvement in the control (medication unchanged) group also first became evident. These results support the hypothesis that the continued long-term use of phenothiazine compounds in chronically-hospitalized psychotics is effective in the sustained reduction of psychopathological behaviour. An investigation of trifluoperazine and chlorprothixene within the same double-blind design indicated that both were significantly more effective than placebo in maintaining the behavioural level typical of the prior long-term medication with phenothiazines. Using the FPN test as one measure of the time course of urinary excretion of some of the phenothiazine metabolites, no relationship was demonstrated in the placebo-substituted group between FPN changes and behavioural worsening. The FPN test, rated blind, was able to discriminate the placebo-substituted group from the group continuing to receive their usual phenothiazines; as a single measure of the time course of urinary excretion of phenothiazine metabolites, however, FPN changes were not related to behavioural worsening within the placebo-substituted group.

scholarly journals Hypericum perforatum versus fluoxetine in the treatment of mild to moderate depression: a randomized double-blind trial in a Brazilian sample

2006 ◽  
Vol 28 (1) ◽  
pp. 29-32 ◽  
Author(s):  
Ricardo Alberto Moreno ◽  
Chei Tung Teng ◽  
Karla Mathias de Almeida ◽  
Hildeberto Tavares Junior
Keyword(s):  
Hypericum Perforatum ◽  
Rating Scale ◽  
Double Blind Trial ◽  
Double Blind ◽  
Brazilian Sample ◽  
Blind Trial ◽  
Intention To Treat ◽  
Moderate Depression ◽  
Antidepressant Efficacy ◽  
Efficacy Measures

OBJETIVE: Hypericum perforatum has demonstrated antidepressant efficacy when compared to placebo, but comparisons with other antidepressants remain controversial. We assessed the efficacy and safety of Hypericum perforatum in comparison with fluoxetine, in a 8-week double-blind trial in patients with mild to moderate depression. METHOD: Seventy-two outpatients were randomly assigned to receive Hypericum perforatum 900 mg/day, fluoxetine 20 mg/day or placebo. Efficacy measures included the HAM-D21 scale, the Montgomery-Åsberg Rating Scale, and the Clinical Global Impression. Safety was assessed with the UKU Side Effect Rating Scale. RESULTS: Intention-to-treat analysis showed no differences between the mean scores of the three groups. In the analyses of observed cases, patients receiving Hypericum perforatum had the lowest remission rates (12%, p = 0.016) compared to fluoxetine (34.6%) and placebo (45%). CONCLUSIONS: Hypericum perforatum was less efficacious than both fluoxetine and placebo. Both drugs were safe and well-tolerated. Larger trials are needed for definite conclusions.

Clinical and Pharmacokinetic Factors Affecting Response to Phenelzine

1980 ◽  
Vol 136 (4) ◽  
pp. 359-365 ◽  
Author(s):  
Peter Tyrer ◽  
Martin Gardner ◽  
John Lambourn ◽  
Mervyn Whitford
Keyword(s):  
Clinical Response ◽  
Monoamine Oxidase Inhibitor ◽  
Oxidase Inhibitor ◽  
Response To Treatment ◽  
Similar Response ◽  
Neurotic Disorder ◽  
Double Blind ◽  
Factors Affecting ◽  
Acetylator Status ◽  
Normal Dosage

SummarySixty patients, 30 with depressive neurosis, 15 with anxiety neurosis and 15 with phobic anxiety states, were treated with the monoamine oxidase inhibitor, phenelzine, in two different dosage schedules for four weeks. All patients received an initial dose of 15 mg daily, increasing to 30 mg daily between the third and seventh day, but subsequently, using double-blind procedure, one group took the commonly prescribed dose of 45 mg daily and the other took 90 mg daily. Acetylator status was independently determined before the start of treatment. Each diagnostic group showed a similar response to treatment, but patients taking the higher dose improved significantly more than those taking normal dosage, and the rate of improvement, measured by weekly self-ratings, was also more rapid with higher dosage. Acetylator status did not affect clinical response. The results suggest that dosage is more important in determining clinical response to phenelzine in neurotic disorder than specific diagnosis or acetylator status.

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