An open label pilot study of citalopram for depression and boredom in ambulatory cancer patients

2003 ◽  
Vol 1 (1) ◽  
pp. 71-77 ◽  
Author(s):  
DALE E. THEOBALD ◽  
KENNETH L. KIRSH ◽  
ELIZABETH HOLTSCLAW ◽  
KATHLEEN DONAGHY ◽  
STEVEN D. PASSIK
Keyword(s):  
Depressive Symptoms ◽  
Pilot Study ◽  
Cancer Patients ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Depression Scale ◽  
Evidence Base ◽  
Open Label ◽  
Double Blind ◽  
Visual Analog Scales

Objective: Significant levels of depressive symptoms are an impediment to adjustment and affect greater than one-third of people with cancer. The clinical diagnosis of major depression is estimated to occur in 25%. Depression is dramatically underrecognized by oncologists and oncology nurses, and as a result, often undertreated. Clinical experience suggests that antidepressants of virtually all types are well tolerated and potentially efficacious. There is, however, a lack of an evidence base for the use of antidepressants in cancer patients.Methods: We undertook an open-label pilot study using citalopram in 30 cancer patients who reported a high level of depressive symptoms on the Zung Self-Rating Depression Scale (ZSDS). In addition to the ZSDS, eligible patients completed a series of visual analog scales for pain, depression, and sleep disturbance; the Functional Assessment of Cancer Therapy-General Module; and the Purposelessness, Understimulation, and Boredom Scale developed by the research team. Patients began a 2-month course of therapy with citalopram 20 mg, increasing to 40 mg at the end of the fourth week if the patient was in the same range of depressive symptoms as measured by the ZSDS.Results: Twenty-one of 30 patients completed the protocol. The average age of the sample was 57.32 years (SD = 12.6) and was comprised of 11 women (52.4%) and 10 men (47.6%). Depressive symptoms decreased and quality of life improved during the 8-week treatment period. Of special interest was the rate of improvement in boredom, and using the total boredom score of the PUB, significant improvement compared to baseline was seen in weeks 6 (F = 5.266, p < .05) and 8 (F = 9.248, p < .01).Significance of results: Overall, the positive findings suggest the need for a randomized, double-blind, placebo-controlled trial of citalopram in cancer patients. Regarding the interplay of boredom and depression, the relationship between improvements in depressive symptoms and boredom is complex. This is illustrated by the way in which the different elements respond to antidepressant treatment. Depression began to improve almost immediately upon initiation of treatment whereas improvement in boredom does not become evident until week 6.

scholarly journals Effects of bright light therapy for depression during pregnancy: a randomised, double-blind controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038030
Author(s):  
Babette Bais ◽  
Astrid M Kamperman ◽  
Hilmar H Bijma ◽  
Witte JG Hoogendijk ◽  
Jan L Souman ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Pregnant Women ◽  
Rating Scale ◽  
Controlled Trial ◽  
Depression Scale ◽  
Bright Light ◽  
Light Therapy ◽  
Secondary Outcome ◽  
Bright Light Therapy ◽  
Double Blind

ObjectivesApproximately 11%–13% of pregnant women suffer from depression. Bright light therapy (BLT) is a promising treatment, combining direct availability, sufficient efficacy, low costs and high safety for both mother and child. Here, we examined the effects of BLT on depression during pregnancy.DesignRandomised, double-blind controlled trial.SettingPrimary and secondary care in The Netherlands, from November 2016 to March 2019.Participants67 pregnant women (12–32 weeks gestational age) with a DSM-5 diagnosis of depressive disorder (Diagnostic and Statistical Manual of Mental Disorders).InterventionsParticipants were randomly allocated to treatment with either BLT (9000 lux, 5000 K) or dim red light therapy (DRLT, 100 lux, 2700 K), which is considered placebo. For 6 weeks, both groups were treated daily at home for 30 min on awakening. Follow-up took place weekly during the intervention, after 6 weeks of therapy, 3 and 10 weeks after treatment and 2 months postpartum.Primary and secondary outcome measuresDepressive symptoms were measured primarily with the Structured Interview Guide for the Hamilton Depression Scale—Seasonal Affective Disorder. Secondary measures were the Hamilton Rating Scale for Depression and the Edinburgh Postnatal Depression Scale. Changes in rating scale scores of these questionnaires over time were analysed using generalised linear mixed models.ResultsMedian depression scores decreased by 40.6%–53.1% in the BLT group and by 50.9%–66.7% in the DRLT group. We found no statistically significant difference in symptom change scores between BLT and DRLT. Sensitivity and post-hoc analyses did not change our findings.ConclusionsDepressive symptoms of pregnant women with depression improved in both treatment arms. More research is necessary to determine whether these responses represent true treatment effects, non-specific treatment responses, placebo effects or a combination hereof.Trial registration numberNTR5476.

Epoetin delta in the management of anaemia in cancer patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19555-19555
Author(s):  
K. Zajda ◽  
M. Krzakowski
Keyword(s):  
Cancer Patients ◽  
Controlled Trial ◽  
Gene Activation ◽  
Human Cell Line ◽  
Primary Objective ◽  
Open Label ◽  
Double Blind ◽  
Target Sample Size ◽  
Number Of Patients ◽  
Transfusion Requirements

19555 Background: Cancer is often associated with anaemia. Epoetin delta (Shire plc) differs from recombinant erythropoietins as it is produced in a human cell line using gene-activation technology. We report data from a controlled trial of epoetin delta (ED) and an extension study. Methods: Cancer patients with anaemia (haemoglobin [Hb] = 10.5 g/dL) were randomized to 12-weeks’ treatment with ED (150 or 300 IU/kg) or placebo (double blind). Treatment was given subcutaneously, three-times weekly. Patients were included if they were receiving chemotherapy and had at least two cycles remaining when randomized. Primary objective was to demonstrate a difference between ED and placebo in Δ Hb from baseline and the number of patients requiring blood transfusions. Target sample size was 100 patients per arm (99% power for a 1.6 g/dL difference in Δ Hb and a 29% difference in the percentage of patients requiring transfusions). Patients completing the study entered an open-label, 12-week extension in which all initially received ED 150 IU/kg. Dose could be increased to 300 IU/kg if Hb levels were < 12 g/dL after 4 weeks. Results: In total, 313 patients were randomized (100, 103 and 99 to ED 150 and 300 IU/kg, and placebo, respectively). Mean change ± SD in Hb from baseline was 2.47 ± 2.39, 2.46 ± 2.56 and 0.57 ± 1.7 in the ED 150 and 300 IU/kg, and placebo groups respectively (P < 0.0001 for both comparisons). There was no difference in the proportion of patients requiring transfusions (26.0, 21.9 and 26.9%, respectively). In the second study, Hb levels were maintained in those previously on ED and increased in those previously on placebo (2.55 g/dL). In those previously on ED, transfusion requirements were lower. ED was well tolerated. Conclusions: Epoetin delta was effective in increasing Hb levels in patients with anaemia related to cancer and longer treatment was associated with fewer transfusions. No significant financial relationships to disclose.

scholarly journals Clinical impact of melatonin on breast cancer patients undergoing chemotherapy; effects on cognition, sleep and depressive symptoms: A randomized, double-blind, placebo-controlled trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (4) ◽  
pp. e0231379 ◽  
Author(s):  
Ana Claudia Souza Palmer ◽  
Maxciel Zortea ◽  
Andressa Souza ◽  
Vinicius Santos ◽  
Jorge Villanova Biazús ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Depressive Symptoms ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Clinical Impact ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals The effect of levothyroxine therapy on depressive symptoms in adults with subclinical hypothyroidism

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
L Wildisen ◽  
C Del Giovane ◽  
M Feller ◽  
E Moutzouri ◽  
S Mooijaart ◽  
...  
Keyword(s):  
Placebo Group ◽  
Depressive Symptoms ◽  
Subclinical Hypothyroidism ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Geriatric Depression Scale ◽  
Depression Scale ◽  
Double Blind ◽  
The Mean ◽  
Using Data

Abstract Background Levothyroxine is one of the most commonly prescribed drugs. A common reason for levothyroxine treatment on patients with subclinical hypothyroidism are depressive symptoms. A meta-analysis of four RCTs (n = 278) found no benefit of levothyroxine therapy on depressive symptoms. However, the confidence interval does not exclude a small clinical benefit. We aim to assess the effect of levothyroxine therapy for depressive symptoms in patients with subclinical hypothyroidism using data from a RCT with more than 400 adults. Methods The TRUST trial was a double-blind, randomized, placebo-controlled trial involving adults aged ≥65y with subclinical hypothyroidism (elevated TSH levels (4.6-19.9 mU/L) and free thyroxine within the reference range). The outcome was depressive symptoms after 12 months based on the Geriatric Depression Scale (GDS-15), a 15-item questionnaire (range: 0 to 15, higher scores indicate more depressive symptoms, minimal clinical important difference: 2). The multivariable linear regression model was adjusted for levothyroxine starting dose, sex, site, and GDS-15 baseline score. Results 425 Swiss and Dutch adults with subclinical hypothyroidism were randomised (mean age 75y, 56% female). The mean (SD) TSH was 6.6 (2.1) mU/L at baseline and after 12 months decreased to 3.8 (2.3) mU/L in the levothyroxine group vs 5.9 (2.7) mU/L in the placebo group. At baseline, the mean GDS-15 score was 1.3 (1.9) in the levothyroxine group and 1.0 (1.6) in the placebo group. The mean GDS-15 score at 12 months was 1.4 (2.1) in the levothyroxine and 1.1 (1.7) in the placebo group with an adjusted between-group difference of 0.2 for levothyroxine vs. placebo (95% CI:-0.1 to 0.5; p = 0.29). Conclusions In this by far largest RCT on the topic, levothyroxine therapy did not confer a benefit for depressive symptoms. Consequently, our results do not support the practice of prescribing levothyroxine for depressive symptoms when they co-occur with subclinical hypothyroidism. Key messages Levothyroxine has no benefit on depressive symptoms in patients with subclinical hypothyroidism. Levothyroxine prescription to patients with subclinical hypothyroidism and depressive symptoms should be reconsidered.

scholarly journals The clinical effectiveness of using a predictive algorithm to guide antidepressant treatment in primary care (PReDicT): an open-label, randomised controlled trial

2021 ◽  
Author(s):  
Michael Browning ◽  
Amy C. Bilderbeck ◽  
Rebecca Dias ◽  
Colin T. Dourish ◽  
Jonathan Kingslake ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Functional Outcome ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Open Label ◽  
Predictive Algorithm ◽  
Depressed Patients ◽  
Randomised Controlled

AbstractDepressed patients often do not respond to the first antidepressant prescribed, resulting in sequential trials of different medications. Personalised medicine offers a means of reducing this delay; however, the clinical effectiveness of personalised approaches to antidepressant treatment has not previously been tested. We assessed the clinical effectiveness of using a predictive algorithm, based on behavioural tests of affective cognition and subjective symptoms, to guide antidepressant treatment. We conducted a multicentre, open-label, randomised controlled trial in 913 medication-free depressed patients. Patients were randomly assigned to have their antidepressant treatment guided by a predictive algorithm or treatment as usual (TaU). The primary outcome was the response of depression symptoms, defined as a 50% or greater reduction in baseline score of the QIDS-SR-16 scale, at week 8. Additional prespecified outcomes included symptoms of anxiety at week 8, and symptoms of depression and functional outcome at weeks 8, 24 and 48. The response rate of depressive symptoms at week 8 in the PReDicT (55.9%) and TaU (51.8%) arms did not differ significantly (odds ratio: 1.18 (95% CI: 0.89–1.56), P = 0.25). However, there was a significantly greater reduction of anxiety in week 8 and a greater improvement in functional outcome at week 24 in the PReDicT arm. Use of the PReDicT test did not increase the rate of response to antidepressant treatment estimated by depressive symptoms but did improve symptoms of anxiety at week 8 and functional outcome at week 24. Our findings indicate that personalisation of antidepressant treatment may improve outcomes in depressed patients.

Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial

2020 ◽  
pp. 27-37
Author(s):  
Suresh Durgam ◽  
Willie Earley ◽  
Rui Li ◽  
Dayong Li ◽  
Kaifeng Lu ◽  
...  
Keyword(s):  
Safety Profile ◽  
Relapse Prevention ◽  
Controlled Trial ◽  
Fixed Dose ◽  
Open Label ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Controlled ◽  
Time To Relapse

Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97 weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3—9 mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9 mg/d) or placebo for double-blind treatment (up to 72 weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n = 99) or cariprazine (n = 101). Time to relapse was significantly longer in cariprazine — versus placebo-treated patients (P = .0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI] = 0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥ 10% of patients during open-label treatment; there were no cariprazine adverse events ≥ 10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060. Key words: schizophrenia; cariprazine; long-term treatment; relapse prevention; randomized controlled trial; oral antipsychotics

Evaluating Thrombin Inhibition in Alzheimer’s Disease (The BEACON Trial): Protocol for a Pilot Study (Preprint)

2019 ◽  
Author(s):  
Cláudia Yang Santos ◽  
Christine Getter ◽  
John Stoukides ◽  
Brian Ott ◽  
Stephen Salloway ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Cognitive Performance ◽  
Thrombin Inhibitor ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind ◽  
Thrombin Inhibition ◽  
Approved Drugs

BACKGROUND The precise mechanisms whereby cardiovascular risk factors increase the risk of Alzheimer’s disease (AD) have not been delineated. We reported that microvessels isolated from AD brains overexpress a diverse array of neurotoxic and inflammatory proteins, which is consistent with the process of vascular activation. In pre-clinical studies using AD animal models we showed that a vascular activation inhibitor reduced vascular-derived neuroinflammation and improved cognitive performance. Thrombin is a key mediator of cerebrovascular activation in AD. OBJECTIVE This study aims to investigate the safety and potential efficacy of the direct thrombin inhibitor dabigatran, in patients with mild cognitive impairment (MCI) or mild AD to decrease vascular-derived neuroinflammation and improve cognitive performance. METHODS Participants will be enrolled then evaluated quarterly throughout the 24-month study. This is a 24-month randomized-control, double-blind, placebo-controlled, multicenter, delayed-start, pilot study evaluating thrombin inhibition in people with biomarker-confirmed MCI probably due to AD or mild AD. 40 - 60 participants will be recruited between 50 - 85 years old. In the initial 9-months of study, either dabigatran or placebo will be orally administered to patients at a dose of 150 mg per day. After 9 months of the placebo-control (Phase I), the placebo arm will cross-over to an active, open-label (Phase II) where all patients will be treated with a 150 mg daily dose of dabigatran orally for an additional 12 months. A 3-month non-treatment follow-up period will assess duration of effects. RESULTS Beginning in July 2019, and concluding in August 2022, this study is expected to publish final results in January 2023. CONCLUSIONS BEACON is a first-in-kind randomized clinical trial targeting thrombin activation in AD therapeutics. This trial will stimulate translational investigations of an FDA-approved drugs in a newly defined therapeutic areas. CLINICALTRIAL Clinicaltrials.gov NCT03752294

scholarly journals Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ekaterina Alexeeva ◽  
Gerd Horneff ◽  
Tatyana Dvoryakovskaya ◽  
Rina Denisova ◽  
Irina Nikishina ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Controlled Trial ◽  
Randomized Study ◽  
Primary Objective ◽  
Disease State ◽  
Inactive Disease ◽  
Open Label ◽  
Standard Regimen ◽  
Double Blind ◽  
Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n = 35) or placebo+MTX (n = 33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p = 0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/−IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients. Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.

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