Prophylactic effect of citalopram in unipolar, recurrent depression

BackgroundMajor depression is highly recurrent. Antidepressant maintenance treatment has proven efficacy against recurrent depression.AimsComparison of prophylactic efficacy of citalopram versus placebo in unipolar, recurrent depression.MethodsPatients 18–65 years of age with recurrent unipolar major depression (DSM–IV), a Montgomery–åsberg Depression Rating Scale score of ≥ 22 and two or more previous depressive episodes, one within the past 5 years, were treated openly with citalopram (20–60 mg) for 6–9 weeks and, if responding, continued for 16 weeks before being randomised to double-blind maintenance treatment with citalopram or placebo for 48–77 weeks.ResultsA total of 427 patients entered acute treatment and 269 were randomised to double-blind treatment. Time to recurrence was longer in patients taking citalopram than in patients taking placebo (P < 0.001). Prophylactic treatment was well tolerated.ConclusionsCitalopram (20, 40 and 60 mg) is effective in the prevention of depressive recurrences. Patients at risk should continue maintenance treatment at the dose necessary to resolve symptoms in the acute treatment phase.

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Once-a-Day Trazodone in the Treatment of Depression in Routine Clinical Practice

Pharmacology ◽

10.1159/000492079 ◽

2018 ◽

Vol 102 (3-4) ◽

pp. 206-212 ◽

Cited By ~ 6

Author(s):

Eva Češková ◽

Michaela Šedová ◽

Renata Kellnerová ◽

Olga Starobová

Keyword(s):

Clinical Practice ◽

Acute Treatment ◽

Rating Scale ◽

Severe Depression ◽

Treatment Phase ◽

Mean Value ◽

Routine Clinical Practice ◽

Release Formulation ◽

Extended Release Formulation ◽

Depressive Episodes

Objective: The aim of the study was to evaluate the efficacy, tolerability, and safety of once-a day trazodone tablets (Trittico Prolong® 300 mg) in patients with moderate to severe depression in routine clinical practice. Methods: Men and women ≥18 years old with Montgomery-Åsberg Depression Rating Scale (MADRS) scores > 21 and Clinical Global Impression – Severity (CGI/S) ≥4 were included in this post-authorization, non-interventional, observational prospective safety study, conducted in 8 psychiatric centers in the Czech Republic. The acute treatment phase lasted 5 weeks: 1 week of titration and 4 weeks of full-dose treatment. Patients had follow-up visits 9 and 21 weeks after commencing treatment. Results: Overall, 85 patients were enrolled in the study, of which 80 completed the acute treatment of 5 weeks. There were significant decreases in the overall MADRS score from the baseline mean value of 27.4–21.2 at week 1 (p < 0.001), and a further decrease to 7.9 at week 5 (p < 0.001). The severity of depression according to CGI/S gradually declined. Most patients reported improvement after 6 days of trazodone treatment. The most frequent adverse drug reactions (ADRs) reported were somnolence and fatigue. Conclusions: Trazodone, in the new extended-release formulation, had very good effects in clinical practice, both in previously untreated depressive episodes and in episodes not responsive to previous antidepressive therapy.

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Treatment of bipolar depression with supraphysiologic doses of levothyroxine: a randomized, placebo-controlled study of comorbid anxiety symptoms

International Journal of Bipolar Disorders ◽

10.1186/s40345-019-0155-y ◽

2019 ◽

Vol 7 (1) ◽

Author(s):

Maximilian Pilhatsch ◽

Thomas J Stamm ◽

Petra Stahl ◽

Ute Lewitzka ◽

Anne Berghöfer ◽

...

Keyword(s):

Bipolar Disorder ◽

Rating Scale ◽

Bipolar Depression ◽

Phenotypic Expression ◽

Anxiety Symptoms ◽

Controlled Study ◽

Double Blind ◽

Comorbid Anxiety ◽

Depressed Patients ◽

Depressive Episodes

Abstract Background Symptoms of anxiety co-occur in a variety of disorders including in depressive episodes of bipolar disorder and in patients with thyrotoxicosis. Treatment of refractory bipolar disorder with supraphysiologic doses of levothyroxine (L-T4) has been shown to improve the phenotypic expression of the disorder and is associated with an increase of circulating thyroid hormones. However, it might be associated with somatic and mental adverse effects. Here we report the investigation of the influence of treatment with supraphysiologic doses of L-T4 on symptoms of anxiety in patients with refractory bipolar depression. Methods Post-hoc analysis from a 6-week, multi-center, randomized, double-blind, placebo-controlled study of the effects of supraphysiologic L-T4 treatment on anxiety symptoms in bipolar depression. Anxiety symptoms were measured weekly with the Hamilton anxiety/somatization factor (HASF) score of the Hamilton Depression Rating Scale (HAMD) and the State- and Trait Anxiety Inventory (STAI). Results Treatment of both groups was associated with a significant reduction in anxiety symptoms (p < 0.001) with no statistical difference between groups (LT-4: from 5.9 (SD = 2.0) at baseline to 3.7 (SD = 2.4) at study end; placebo: from 6.1 (SD = 2.4) at baseline to 4.4 (SD = 2.8) at study end; p = 0.717). Severity of anxiety at baseline did not show a statistically significant correlation to the antidepressive effect of treatment with supraphysiologic doses of L-T4 (p = 0.811). Gender did not show an influence on the reduction of anxiety symptoms (females: from 5.6 (SD = 1.7) at baseline to 3.5 (SD = 2.4) at study end; males: from 6.1 (SD = 2.3) at baseline to 4.0 (SD = 2.4) at study end; p = 0.877). Conclusions This study failed to detect a difference in change of anxiety between bipolar depressed patients treated with supraphysiologic doses of L-T4 or placebo. Comorbid anxiety symptoms should not be considered a limitation for the administration of supraphysiologic doses of L-T4 refractory bipolar depressed patients. Trial registration ClinicalTrials, ClinicalTrials.gov identifier: NCT01528839. Registered 2 June 2012—Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT01528839

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Fenetyline as possible treatment in non-responder depressive patients

Psychiatry and Psychobiology ◽

10.1017/s0767399x00003345 ◽

1990 ◽

Vol 5 (1) ◽

pp. 29-30

Author(s):

F Lang ◽

J Pellet ◽

B Estour

Keyword(s):

Major Depression ◽

Sleep Deprivation ◽

Therapeutic Response ◽

Manic Episode ◽

Endogenous Depression ◽

Recurrent Depression ◽

Different Types ◽

Depressive Episodes ◽

Depressive Patients

SummaryThe authors report the case of a 45-yr-old male who presented from 1979 to 1986 with several severe depressive episodes. The patient fulfilled Feighner criteria for major depression, Newcastle criteria for endogenous depression: the depressive episodes were all classified as severe recurrent depression without melancholia according to DSM III. The patient was resistant to different types of treatment (ECT, tricyclic and MAOI drugs, lithium, sleep deprivation). With a treatment of 10 cg/day of fenetyline, reduced to 5 cg/day after 6 months, (atypical manic episode), the patient improved considerably for 20 rnonths. The therapeutic response decreased after this period but after a month of withdrawal, the patient again responded. The authors cannot explain the duration of this therapeutic response.

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Comparative Efficacy and Safety of Sertraline Versus Nortriptyline in Major Depression in Patients 70 and Older

International Psychogeriatrics ◽

10.1017/s104161029900561x ◽

1999 ◽

Vol 11 (1) ◽

pp. 85-99 ◽

Cited By ~ 41

Author(s):

Sanford I. Finkel ◽

Ellen M. Richter ◽

Cathryn M. Clary

Keyword(s):

Major Depression ◽

Rating Scale ◽

Antidepressant Treatment ◽

Change Score ◽

Attrition Rate ◽

Double Blind ◽

Almost All ◽

Positive Effect ◽

Population Segment

Background. Few randomized, double-blind studies that examine antidepressant treatment in patients 70 years and older are available. To provide additional data on the safety and efficacy of antidepressants in this rapidly growing population segment, a subgroup analysis of a larger sertraline vs. nortriptyline elderly depression treatment study was performed. Methods. Outpatients (N = 76) who met DSM-III-R criteria for major depression with a minimum Hamilton Depression Rating Scale (HAM-D) severity score of 18 were randomized to 12 weeks of flexible dose treatment with sertraline (50–150 mg) or nortriptyline (25–100 mg). Results. Both treatments significantly improved depression as measured by the HAM-D and Clinical Global Impression scales. At Weeks 10, 12, and endpoint, sertraline demonstrated a significantly greater reduction in depression severity compared to nortriptyline as measured by improvement on the 24-item HAM-D (mean adjusted change score of 14.8 vs. 7.6, respectively, at Week 12; p = .001). Sixty-five percent of sertraline-treated patients were responders by Week 12 (50% or greater reduction from baseline in 24-item HAM-D score) compared to 26% of nortriptyline-treated patients (p < .05). Sertraline treatment had a significantly more positive effect, when compared to nortriptyline, across almost all associated measures of cognitive function, energy, anxiety, and quality of life and was better tolerated than nortriptyline, with a lower attrition rate/side effect burden. Conclusion. The efficacy advantage of sertraline appeared to be even greater in this subgroup of older patients drawn from a larger treatment study of depression that included elderly individuals over the age of 60.

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An Open Study of Sertraline in Acute and Continuation Treatment of Depressed Out-Patients

Journal of International Medical Research ◽

10.1177/030006059702500604 ◽

1997 ◽

Vol 25 (6) ◽

pp. 340-353 ◽

Cited By ~ 3

Author(s):

B Van Houdenhove ◽

P Onghena ◽

M Flows ◽

F Janssen ◽

AR De Nayer ◽

...

Keyword(s):

Major Depression ◽

Open Study ◽

Acute Treatment ◽

Rating Scale ◽

Severity Of Illness ◽

Final Visit ◽

Clinical Global Impression Scale ◽

Scale Scores ◽

Insufficient Response ◽

Continuation Treatment

The efficacy and tolerability of sertraline in 422 out-patients with major depression (DSM-III-R) was evaluated in an open multicentre 8-month study. Patients received sertraline 50 mg/day; if there was insufficient response at week 4, the dose was increased to 100 mg/day. After 8 weeks, 68.6% of patients had responded (≥ 50% reduction in Montgomery Åsberg depression rating scale and clinical global impression scale scores of two or less (improvement of illness) and three or less (severity of illness); of patients receiving continuation treatment, 87.9% maintained at least a partial response at the final visit. The clinical response to the 50 mg/day dose was maintained throughout the acute treatment in 64% of patients. In all, 23% of the patients had mild or moderate drug-related gastrointestinal disturbances, which generally disappeared after 2 weeks. Only 8% of the patients withdrew because of side-effects. Just over half of the patients were taking other psychotropic drugs. Nevertheless the results of this open study are consistent with those of controlled studies in which sertraline was effective and well tolerated, in acute and continuation treatment for major depression, at 50 mg/day in most patients.

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154 Functioning in de Novo and Rollover Patients with Bipolar I Disorder Receiving Aripiprazole Once-monthly in a 52-Week, Open-label Study

CNS Spectrums ◽

10.1017/s109285292000070x ◽

2020 ◽

Vol 25 (2) ◽

pp. 298-299

Author(s):

Jessica J Madera ◽

Pedro Such ◽

Maxine Chen ◽

Ross A Baker

Keyword(s):

Depressive Symptoms ◽

Maintenance Treatment ◽

Rating Scale ◽

De Novo ◽

Open Label ◽

Safety Study ◽

Double Blind ◽

Double Blind Placebo ◽

Term Maintenance

Abstract:Introduction:Long-term maintenance treatment is essential in management of bipolar I disorder (BP-I) to achieve mood stability, prevent recurrence of mood episodes and improve functioning. Aripiprazole once-monthly 400 mg (AOM 400) is a long-acting formulation of aripiprazole for maintenance treatment of BP-I. In a double-blind, placebo-controlled, randomized withdrawal study in adult patients with BP-I after a manic episode (NCT01567527), AOM 400 delayed time to and reduced rate of recurrence of mood episodes and was safe and well tolerated (1). In an open-label, long-term safety study (NCT01710709), AOM 400 was safe and effective as long-term maintenance treatment (2).Objective:To evaluate the effect of long-term AOM 400 maintenance treatment on manic and depressive symptoms in BP-I patients from the open-label, long term safety study.Methods:Manic and depressive symptoms were assessed post-hoc by analysis of change from study entry in the Young-Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) total scores and line item scores. The mean changes from baseline at last visit in YMRS and MADRS total scores, and single items were calculated using descriptive statistics, using last observation carried forward for total scores and observed cases for single items.Results:A total of 464 patients entered the maintenance phase: 379 were de novo and 85 were rollover patients who completed the double-blind, placebo-controlled withdrawal study. Overall, 63% (291/464) completed 52 weeks of open-label treatment. Mean YMRS and MADRS total scores were minimally changed from baseline (YMRS: 2.31, endpoint change -0.30; MADRS: 3.23, endpoint change +1.24) across the study in the total population.Conclusion:Patients entering an open-label safety study with stable manic and depressive symptoms maintained stability in both types of symptoms, as shown by minimal mean changes from baseline in YMRS and MADRS scores, suggesting that treatment with AOM 400 is effective in preventing re-emergence of both manic and depressive symptoms.Funding Acknowledgements:The study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.

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Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies

CNS Spectrums ◽

10.1017/s1092852914000285 ◽

2014 ◽

Vol 20 (2) ◽

pp. 140-147 ◽

Cited By ~ 15

Author(s):

Henry A. Nasrallah ◽

Josephine B. Cucchiaro ◽

Yongcai Mao ◽

Andrei A. Pikalov ◽

Antony D. Loebel

Keyword(s):

Depressive Symptoms ◽

Rating Scale ◽

Antipsychotic Agent ◽

Pooled Analysis ◽

Double Blind ◽

Madrs Score ◽

Level Data ◽

Post Hoc ◽

Major Depressive Episodes ◽

Depressive Episodes

ObjectiveDepressive symptoms are common in schizophrenia and can worsen outcomes and increase suicide risk. Lurasidone is an atypical antipsychotic agent indicated for the treatment of schizophrenia and for the treatment of major depressive episodes associated with bipolar I disorder. This post hoc analysis evaluated the effect of lurasidone on depressive symptoms in patients with schizophrenia.MethodsPatient-level data were pooled from 4 similarly designed, double-blind, placebo-controlled, 6-week registration studies of lurasidone (40–160 mg/d) in adult patients with an acute exacerbation of schizophrenia. Changes in depressive symptoms, measured by the Montgomery–Åsberg Depression Rating Scale (MADRS), were analyzed for the overall sample and for subgroups of patients stratified by baseline MADRS scores.ResultsMADRS assessments at baseline and endpoint (day 42 or last observation carried forward [LOCF]) were available for 1330 patients. Patients receiving lurasidone experienced significantly greater decreases in MADRS score (–2.8, least-squares [LS] mean change, LOCF) compared with patients receiving placebo (–1.4, P < .001, effect size 0.24). Analysis of change in MADRS score (LOCF) by baseline symptom severity (MADRS score of ≥12, ≥14, ≥16, ≥18) showed significantly greater improvement for lurasidone-treated patients across all severity groups; effect sizes ranged from 0.25 to 0.34. Among patients with a baseline MADRS score of ≥12, depressive symptom remission (defined as MADRS score <10 at LOCF endpoint) was attained by 45.0% of lurasidone-treated patients and 36.3% of patients receiving placebo (P < .05).ConclusionsIn a pooled analysis of short-term, placebo-controlled studies, lurasidone significantly improved depressive symptoms in patients with schizophrenia.

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Adjunctive tianeptine treatment for bipolar disorder: A 24-week randomized, placebo-controlled, maintenance trial

Journal of Psychopharmacology ◽

10.1177/0269881119826602 ◽

2019 ◽

Vol 33 (4) ◽

pp. 502-510 ◽

Cited By ~ 4

Author(s):

Márcia Kauer-Sant’Anna ◽

Benicio N Frey ◽

Adam Fijtman ◽

Ana C Loredo-Souza ◽

Aroldo A Dargél ◽

...

Keyword(s):

Maintenance Treatment ◽

Rating Scale ◽

Bipolar Depression ◽

Biological Rhythms ◽

Preliminary Evidence ◽

Rank Test ◽

Cognitive Effect ◽

Open Label ◽

Double Blind ◽

Adult Intelligence Scale

Objective: The purpose of this study was to assess the efficacy and tolerability of tianeptine as an adjunctive maintenance treatment for bipolar depression. Methods: This is a multicenter double-blind randomized placebo-controlled maintenance trial of adjunctive tianeptine 37.5 mg/day. Participants ( n=161) had a Montgomery-Asberg Depression Rating Scale ⩾12 at entry. After eight weeks of open-label tianeptine treatment, those who responded to tianeptine ( n=69) were randomized to adjunctive tianeptine ( n=36) or placebo ( n=33) in addition to usual treatment. Kaplan-Meier estimates and the Mantel-Cox log-rank test were used to evaluate differences in time to intervention for a mood episode between the tianeptine and placebo groups. We also assessed overall functioning, biological rhythms, quality of life, rates of manic switch and serum brain-derived neurotrophic factor levels. Results: There were no differences between adjunctive tianeptine or placebo regarding time to intervention or depression scores in the 24-week double-blind controlled phase. Patients in the tianeptine group showed better performance in the letter-number sequencing subtest from the Wechsler Adult Intelligence Scale at the endpoint ( p=0.014). Tianeptine was well tolerated and not associated with higher risk for manic switch compared to placebo. Conclusion: Tianeptine was not more effective than placebo in the maintenance treatment of bipolar depression. There is preliminary evidence suggesting a pro-cognitive effect of tianeptine in working memory compared to placebo.

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A Double-Blind, Multicentre Study of Paroxetine and Maprotiline in Major Depression

The Canadian Journal of Psychiatry ◽

10.1177/070674379604100409 ◽

1996 ◽

Vol 41 (4) ◽

pp. 239-244 ◽

Cited By ~ 17

Author(s):

Ulrich Schnyder ◽

Annemarie Koller-Leiser

Keyword(s):

Side Effects ◽

Major Depression ◽

Rating Scale ◽

Similar Efficacy ◽

Nonsignificant Trend ◽

Double Blind ◽

Treatment Groups ◽

Hopkins Symptom Checklist ◽

Psychiatric Rating ◽

Psychiatric Rating Scale

Objective: This study was performed to compare the clinical efficacy, side effects, and safety of paroxetine and maprotiline, the latter being the most frequently prescribed antidepressant in Switzerland. Method: Seventy-one patients (in and outpatients) with major depression were randomly allocated to treatment with paroxetine (20 to 40 mg daily) or with maprotiline (50 to 150 mg daily). Efficacy was measured by means of the Hamilton Psychiatric Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale, the Clinical Global Impression, and the Hopkins Symptom Checklist. Results: The 2 components showed a similar efficacy. The adverse effect profile was comparable in the 2 treatment groups, although the findings showed a nonsignificant trend pointing in the direction of lower side effects with paroxetine. Conclusion: In the moderate dose regimens tested, the 2 components seemed to be of similar efficacy, with comparable profiles of side effects and safety.

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