Report on a Double-Blind Comparison of Two Different Regimens of Dothiepin (Prothiaden)

1983 ◽  
Vol 11 (1) ◽  
pp. 15-20 ◽  
Author(s):  
J Boening
Keyword(s):  
Side Effects ◽  
Therapeutic Effect ◽  
Rating Scale ◽  
Endogenous Depression ◽  
Clinical Impression ◽  
Night Time ◽  
Double Blind ◽  
Significant Difference ◽  
Single Night ◽  
Node Group

Thirty patients diagnosed as suffering from endogenous depression were entered into a 3-week double-blind trial comparing three times a day dosage of dothiepin with a single night-time dosage in a dosage range of 75 mg to 225 mg per day. The trial was conducted on in-patients and assessments were made pretrial and after 1 and 3 weeks. The patients were assessed by clinician-rated scales for psychomotor and psychic symptoms and by Zung's self-rating scale. Fifteen patients received dothiepin three times a day (day-time group) and fifteen received it as a single night-time dose (node group). There were two withdrawals in the day-time group and three in the node group. All withdrawals were due to lack of therapeutic effect. Over the 3-week trial 67% of the day-time group and 47% of the node group showed a clinical improvement. It was found that there was no statistically significant difference between the two methods of treatment. In the day-time group seven patients and in the night-time group nine patients suffered from side-effects. No particular pattern of side-effects emerged. There were no drug-related changes in the laboratory results. It was concluded that the therapeutic effect of both dosage regimes should be regarded as equivalent. Advantages, due to the specific action of dothiepin, compared with classical antidepressants for reference, could, however, not be presumed by the clinical impression.

A Controlled Comparative Trial of a New Antidepressant, Ciclazindol

1979 ◽  
Vol 7 (1) ◽  
pp. 1-6 ◽  
Author(s):  
Sidney Levine
Keyword(s):  
Rating Scale ◽  
Comparative Trial ◽  
Poor Response ◽  
Endogenous Depression ◽  
Depressive Illness ◽  
Double Blind ◽  
Significant Difference ◽  
Severity Of Depression ◽  
The Mean ◽  
Rate Of Response

The author describes a controlled, double-blind, comparative trial of a new tetracyclic compound, ciclazindol (WY 23409), against amitriptyline in the treatment of thirty-five patients admitted to hospital with depressive illness. Each patient was randomly allocated to three weeks treatment with either 50 mg b.d. ciclazindol or 50 mg b.d. amitriptyline. In the event of a poor response the dose level was raised to 75 mg b.d. Separation of cases of endogenous depression and severity of depression were assessed by the Levine-Pilowsky Depression Questionnaire, a self-rating technique. Severity of depression was also assessed using the Hamilton Rating Scale. No significant difference was noted between the drugs in either the degree or the rate of response nor when the endogenous cases alone were studied. The interesting observation was made that only one-third of ciclazindol patients gained weight compared to almost three-quarters of the amitriptyline group and the mean weight gain of the latter was over double that of the ciclazindol group. The author concludes that ciclazindol offers promise and merits further study using higher dosage levels once its full safety trials have been completed.

A Controlled Study of Trancopal in the Treatment of Sleep Disturbances Due to Anxiety

1978 ◽  
Vol 6 (2) ◽  
pp. 115-120 ◽  
Author(s):  
J M T Warnock
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Sleep Disturbances ◽  
Controlled Study ◽  
Night Time ◽  
Double Blind ◽  
Matching Placebo ◽  
Daily Record ◽  
Single Night

Sixty-eight patients presenting with sleep disturbances due to mild neurotic anxiety were treated for two weeks with a single night-time dose of 400 mg Trancopal or matching placebo under double-blind conditions. Patients kept a daily record of the quality of their sleep and the observer carried out a weekly rating of anxiety using a modified Hamilton scale. By Day 7 patients receiving Trancopal had a significantly better rating for sleep and mean Hamilton scores for day-time anxiety than the placebo group. Side-effects were minimal. It was concluded that for patients with sleep disturbances due to neurotic anxiety Trancopal is a well tolerated and effective alternative to the hypnotics.

A Double-Blind Study of Trazodone and Mianserin in the Treatment of Depression in General Practice

1982 ◽  
Vol 10 (3) ◽  
pp. 147-156 ◽  
Author(s):  
H H Richards ◽  
R N Midha ◽  
S Miller
Keyword(s):  
General Practice ◽  
Side Effects ◽  
Therapeutic Effect ◽  
Rating Scale ◽  
Double Blind ◽  
Global Improvement ◽  
Hamilton Depression Rating Scale ◽  
Self Rating ◽  
Visual Analogue Scales ◽  
Analogue Scales

The antidepressant and anxiolytic efficacy of trazodone (100–200 mg daily), mianserin (60–120 mg daily) and diazepam (15–30 mg daily) was evaluated in ninety-three patients suffering from mild to moderate depression, with or without anxiety, over 6 weeks in a double-blind non-crossover general practice study. Efficacy was evaluated using the Hamilton Depression Rating Scale, Patient Self-Rating Visual Analogue scales, physician global assessments and the Zung Self-Rating Anxiety Scale. All three treatments significantly reduced symptoms of depression, as measured on the Hamilton Depression Rating Scale and the physician's assessment of Global Improvement. Trazodone was significantly superior to both mianserin and diazepam. As assessed using Visual Analogue Scales, trazodone was also shown to be significantly superior to diazepam in improving the patient's ability to concentrate and in reducing daytime tiredness. Although evidence of efficacy was found, there were no differences in activity between the treatment groups using the physician's assessment of Current Severity or on assessment of Therapeutic Effect. The treatments all caused a reduction in anxiety as assessed by the Zung Self-Rating Scale. The overall incidence of side-effects was similar between groups. For those side-effects considered to be significantly interfering with the patient's function, but not outweighing the therapeutic effect, a reduction of dosage was effective. Several patients complaining of drowsiness or lethargy as an unacceptable daytime side-effect were switched successfully from twice daily to night-time dosing. Significantly more patients with side-effects (outweighing therapeutic effect or in the presence of no improvement) were withdrawn from the mianserin group than from the trazodone or diazepam groups. Overall, the therapeutic efficacy in relation to the incidence of clinically significant side-effects, favoured trazodone for the treatment of general practice patients suffering from depression, with or without anxiety.

A Double-Blind Comparison of Terfenadine and Mequitazine in the Symptomatic Treatment of Acute Pollinosis

1986 ◽  
Vol 14 (3) ◽  
pp. 124-130 ◽  
Author(s):  
L Hugonot ◽  
R Hugonot ◽  
D Beaumont ◽  
Cahen ◽  
Colomby ◽  
...  
Keyword(s):  
Side Effects ◽  
Rating Scale ◽  
Symptomatic Treatment ◽  
Geographic Area ◽  
Diary Card ◽  
Onset Of Action ◽  
Blurred Vision ◽  
Double Blind ◽  
Significant Difference ◽  
The Difference

This study was a double-blind, parallel group comparison of terfenadine (TRF) 60 mg b.i.d. and mequitazine (MQZ) 5 mg b.i.d. for 7 days in the symptomatic treatment of acute pollinosis. The trial took place in the same geographic area and during the same pollen season (May-July 85), to ensure homogeneity of the study population. The fourteen investigators participating in this multicentre trial recruited 141 patients (69 TRF; 72 MQZ) suffering from well-documented pollinosis, mainly hay fever and sometimes allergy to tree pollens. Symptoms (nasal itching, sneezing, rhinorrhoea, obstruction, conjunctivitis) and possible somnolence were rated daily using a 4-point rating-scale of 0 to 3 by the patient on a diary card. Assessment of over-all efficacy and tolerability – focusing on atropinic side-effects – was made at the end of the seven-days treatment period by the physician, after reviewing the diary card and questioning the patient. The means score profile of each symptom for the study period was similar with the two treatments. Both had a fast onset of action with the regression of the total symptoms' score being already significant at day 1. Over-all assessment of efficacy at day 7 showed no significant difference between the two treatments. The daily somnolence scores however showed a clear and significant difference between the two drugs: the frequency of moderate to marked somnolence from day 2 to 7 was around 15% with MQZ and around 5% on days 2 to 5 and 0% on days 6 and 7 with TRF, the difference being significant on days 2, 5, 6 and 7. The incidence of blurred vision was 7% with MQZ requiring cessation of therapy in one patient, compared with 0% with TRF (p < 0-06). Side-effects other than somnolence and atropinic effects were reported in two TRF and six MQZ patients. In conclusion terfenadine and mequitazine displayed the same efficacy for symptoms of pollinosis, but terfenadinie was better tolerated.

A General Practitioner Study of Dothiepin and Amitriptyline

1974 ◽  
Vol 2 (3) ◽  
pp. 210-213 ◽  
Author(s):  
J Lambourn ◽  
J A Rees
Keyword(s):  
General Practitioner ◽  
Side Effects ◽  
Rating Scale ◽  
Global Scale ◽  
Blind Study ◽  
Double Blind Study ◽  
Depressant Effect ◽  
Double Blind ◽  
Significant Difference ◽  
Unexpected Difference

Forty-one patients completed a four-week double-blind study comparing dothiepin and amitriptyline. The anti-depressant effect of the two drugs was measured by the Hamilton depression rating scale and a five-point global scale. Side-effects were recorded as mild, moderate or severe. Analysis of the results failed to demonstrate a statistically significant difference between the anti-depressant effect of the two drugs, but dothiepin was the favoured therapy in all assessments. Both drugs produced a significant improvement (p < 0·01) after only one week's therapy. The incidence and severity of side-effects were much less with dothiepin. An unexpected difference in the Hamilton scores at the end of the fourth week is to be investigated further.

A Controlled Study Comparing a Three Times Daily Dose of Chlordiazepoxide with a Single Night-Time Dose of Trancopal in the Control of Anxiety, Using a Double-Blind, Double-Dummy Technique

1978 ◽  
Vol 6 (2) ◽  
pp. 105-110 ◽  
Author(s):  
J F Donald ◽  
A Layes Molla
Keyword(s):  
Rating Scale ◽  
Close Correlation ◽  
Controlled Study ◽  
Night Time ◽  
Double Blind ◽  
Daily Dose ◽  
Placebo Capsule ◽  
Single Night ◽  
Over 40 Years ◽  
Usual Dosage

A double-blind, double-dummy between-patient study in general practice was carried out to compare the effectiveness of a single, night-time dosage of Trancopal and a three times daily dose of chlordiazepoxide in controlling neurotic anxiety. Ninety-three patients received either 400 mg of Trancopal at night and a chlordiazepoxide placebo capsule three times daily or 10 mg of chlordiazepoxide three times daily and one or two Trancopal placebo tablets at night. Each was treated for four weeks. Three assessments were made using a physicians' rating scale (modified Hamilton Scale). A visual analogue scale was completed by patients initially and at weekly intervals and physicians' and patients' global assessments were made at Weeks 2 and 4. Each treatment group improved considerably over the period of the study both for sleep and anxiety ratings. A statistically significant correlation was found between improvement in day-time fatigue and loss of energy and improvement in sleep disturbance only in the Trancopal group. Loss of concentration was analyzed separately in patients over 40 years old and there was a significant improvement in the physicians' rating in the Trancopal group. There was a very close correlation throughout between the physician's and patient's own assessment of improvement. Few side-effects not already reported at the start of the trial were reported on either treatment. It was concluded that Trancopal at a usual dosage of 400 mg at night offers an effective alternative to a divided dose of chlordiazepoxide. Not only is the beneficial effect on symptoms of anxiety similar but there is some suggestion of a greater improvement in sleep and less interference with day-time functioning.

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

EEG Synchronized TMS for Individualized Therapy in Major Depressive Disorder

2011 ◽  
Vol 26 (S2) ◽  
pp. 1144-1144
Author(s):  
Y. Jin ◽  
J. Phillips ◽  
Yueqin Huang ◽  
Steven Heurta
Keyword(s):  
Major Depressive Disorder ◽  
Side Effects ◽  
Depressive Disorder ◽  
Active Treatment ◽  
Rating Scale ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Stimulus Frequency ◽  
List Type ◽  
Major Depressive ◽  
Double Blind

IntroductionEfficacy of conventional repetitive transcranial magnetic stimulation (rTMS) in major depressive disorder (MDD) is limited. The authors report here on an alternative treatment using low energy synchronized TMS (sTMS) at the intrinsic frequency of subjects’ alpha electroencephalogram (EEG).ObjectivesEstablish efficacy and safety profile of sTMS in MDD.Aim(1)Examine the clinical effectiveness of sTMS.(2)Identify adverse effects associated with sTMS.MethodsFifty-two MDD subjects with 17-item Hamilton Depression Rating Scale (HAMD17) scores >17 were enrolled into a randomized, sham controlled, double-blind trial. Current medication remained unchanged during the trial. Depressive symptoms were evaluated by HAMD17 administered weekly.EEGs were recorded at baseline to determine the stimulus frequency and at week 4 to evaluate the physiological effect. sTMS was delivered through three 6000-G cylindrical neodymium magnets synchronously rotating at a rate equal to the subject's intrinsic alpha frequency.ResultsForty-five subjects completed at least 1 week of treatment and were evaluable. Those who received active treatment had superior clinical response to sham (t = 2.54, P = 0.01), where 55.2% in the active treatment group were clinical responders versus 12.5% in sham (X2 = 7.82, P = 0.005). No significant side effects were reported. The clinical improvement was correlated with the degree of EEG improvement (r = .46, P = 0.009).ConclusionsA therapeutic effect in MDD subjects can be achieved through administration of sTMS at the subject's alpha EEG frequency. Because of minimal side effects, this appears to be a safe and effective treatment option.

The Efficacy and Tolerability of Combined Antidepressant Treatment in Different Depressive Subgroups

1993 ◽  
Vol 162 (3) ◽  
pp. 363-368 ◽  
Author(s):  
Sinead O'brien ◽  
Patrick McKeon ◽  
Myra O'regan
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Major Depression ◽  
Orthostatic Hypotension ◽  
Antidepressant Treatment ◽  
Combined Treatment ◽  
Endogenous Depression ◽  
Double Blind Study ◽  
Double Blind ◽  
Global Improvement

Eighty patients admitted to hospital with major depression were randomly allocated to six weeks of treatment with tranylcypromine, amitriptyline, or tranylcypromine and amitriptyline in combination, in a double-blind study. Scores on the HRSD improved significantly in all three groups, but there were no differences between the three groups. Patients on tranylcypromine and amitriptyline combined improved more according to their self-ratings after six weeks, and response was earlier as measured by a clinical global improvement scale. Those with endogenous depression improved more than those with neurotic depression, irrespective of treatment group. Combined treatment was less well tolerated than single treatments and gave rise to more side-effects, although there was no serious toxicity. Orthostatic hypotension was observed more frequently in patients on combined treatment. This group also experienced a significant increase in weight and prolongation of the P-R interval on ECG.

scholarly journals Topical Diltiazem Versus Topical Glyceryl Trinitrate In The Management Of Chronic Anal Fissure

JMS SKIMS ◽  
2014 ◽  
Vol 17 (2) ◽  
pp. 55-58
Author(s):  
Shams Ul Bari ◽  
Ajaz Ahmad Malik ◽  
Khurshid Alam Wani ◽  
Ajaz A Rather
Keyword(s):  
Side Effects ◽  
Anal Fissure ◽  
Chronic Anal Fissure ◽  
P Value ◽  
Double Blind ◽  
Surgical Methods ◽  
Significant Difference ◽  
Topical Glyceryl Trinitrate ◽  
One Year

Background: Chemical sphincterotomy is a novel way for treating patients of chronic anal fissure which avoids the risk of fecal incontinence associated with traditional surgical methods. Aims and objectives: The aim of this study was to compare the results of topical Diltiazem with topical Glyceril trinitrate in the management of chronic anal fissure. Methods: 71 patients in the age group of 15 - 61 years with chronic anal fissure were included in this prospective, randomized, double-blind trial over a period of two years with further follow up for one year. The patients were randomly allocated to either Diltiazem gel 2% (37 patients) or Glyceril trinitrate ointment 0.2% (34 patients) and were asked to use the treatment twice daily for 8 weeks. Each patient was reviewed every two weeks. Symptoms, healing, side effects and recurrence were compared using SPSS version 10 employing X2 test. A p-value below 0.05 was considered statistically significant. Results: Patients who received topical diltiazem (DTZ) showed statistically significant difference than those who were prescribed topical glyceril trinitrate in terms of symptoms, wound healing, side effects ( headaches) and recurrence (p=0.03 and 0.003 respectively). Healing occurred in 34 of 37 (92%) patients treated with Diltiazem after 6 weeks and 27 of 34 (80%) patients treated with Glyceril trinitrate after 8 weeks, which shows a significant difference in favour of Diltiazem (P < 0.001). The rest of the patients did not heal and underwent sphincterotomy (SILS). Headache occurred in all of the patients treated with Glyceril trinitrate but none of the patients treated with Diltiazem. Conclusion: Diltiazem gel was found to be better than Glyceril trinitrate ointment due to significantly higher healing rate and fewer side-effects. JMS 2014;17(2):55-58

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