Granisetron Augmentation of Sertraline in Obsessive-Compulsive Disorder: A Double-Blind Placebo-Controlled, Randomized Clinical Trial

Abstract Background: Medications currently recommended for the treatment of Obsessive-Compulsive Disorder (OCD) usually relieve the severity of symptoms by as much as 20–30%, and satisfactory treatment is obtained in 40–60% of patients with OCD. Nevertheless, the remaining symptoms continue to impair the patients’ function. Therefore, it is necessary to investigate possible strategies to improve the mitigation of symptoms.In this study, the main objective was to examine and investigate the effectiveness of granisetron, which is a serotonin 5-hydroxytryptamine receptor type 3 (5-HT3) antagonist, as an adjunct therapy to selective serotonin reuptake inhibitors, for the purpose of ameliorating OCD symptoms. Methods: fifty-eight patients diagnosed with OCD, based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, who had a Yale-Brown obsessive-compulsive scale (Y-BOCS) score of more than 21 were recruited in a double-blinded, parallel-group, placebo-controlled, clinical trial of 10 weeks to receive either granisetron (1 mg twice daily) and sertraline (100 mg daily initially followed by 200 mg daily after week 4) or placebo and sertraline. The primary outcome was OCD symptoms measured by the Y-BOCS.Results: Y-BOCS total score significantly dropped in both groups (28.9 to 17.7 for granisetron and 27.5 to 19.3 for placebo group with a slightly greater drop for granisetron group), while the granisetron group experienced a significantly greater reduction in obsession scores (Greenhouse-Geisser F(2.32,97.57)=4.52,p-value=0.01). Moreover, in comparison with the placebo group, the proportion of the patients showing complete response was considerably higher among the granisetron group (P-value <0.01). No major adverse effects were observed in any of the groups. Conclusion: The results suggest that granisetron augmentation of sertraline may increase the rate of response in patients with moderate to severe non-refractory OCD. Further studies are suggested in this regard.Trial registration: The trial was registered at the Iranian Registry of Clinical Trials on 27/03/2019 (www.irct.ir; IRCT ID: IRCT20170123032145N3).

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Fluvoxamine combination therapy with tropisetron for obsessive-compulsive disorder patients: A placebo-controlled, randomized clinical trial

Journal of Psychopharmacology ◽

10.1177/0269881119878177 ◽

2019 ◽

Vol 33 (11) ◽

pp. 1407-1414 ◽

Cited By ~ 3

Author(s):

Mohammadreza Shalbafan ◽

Farzaneh Malekpour ◽

Borna Tadayon Najafabadi ◽

Kiandokht Ghamari ◽

Seyed-Ali Dastgheib ◽

...

Keyword(s):

Clinical Trial ◽

Obsessive Compulsive Disorder ◽

Selective Serotonin Reuptake Inhibitors ◽

Controlled Clinical Trial ◽

P Value ◽

Obsessive Compulsive ◽

Compulsive Disorder ◽

First Line Therapy ◽

Significant Efficacy ◽

Double Blinded

Background: About 50% of obsessive-compulsive disorder patients still suffer significant symptoms even after the recommended first-line therapy. This demonstrates the necessity to investigate strategies to improve alleviation of symptoms. Objective: The main objective of this study was to investigate the efficacy of a 5-hydroxytryptophan 3 receptor antagonist, tropisetron, as an adjuvant therapy to selective serotonin reuptake inhibitors, in ameliorating obsessive-compulsive disorder symptoms. Methods: Men and women between the ages of 18–60 years diagnosed with obsessive-compulsive disorder, based on DSM5, who had a Yale-Brown obsessive compulsive scale score of more than 21 were recruited in a double-blinded, parallel-group, placebo-controlled, clinical trial of 10 weeks to receive either tropisetron (5 mg twice daily) and fluvoxamine (100 mg daily initially followed by 200 mg daily after week 4) or placebo and fluvoxamine. The primary outcome of interest in this study was the Yale-Brown obsessive compulsive scale total score decrease from baseline. Results: One hundred and eight participants were equally randomized into two groups; 48 participants in each group finished the trial. The Yale-Brown obsessive compulsive total score significantly dropped in both groups while the tropisetron group participants experienced a significantly higher decrease in their scores (Greenhouse-Geisser F(1.53–65.87)=3.516, p-value=0.04). No major adverse effect was observed in any of the groups. Conclusion: This trial showed a significant efficacy for tropisetron over placebo in treatment of obsessive-compulsive disorder symptoms when added to fluvoxamine.

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Pregabalin augmentation for resistant obsessive–compulsive disorder: a double-blind placebo-controlled clinical trial

CNS Spectrums ◽

10.1017/s1092852919001500 ◽

2019 ◽

Vol 25 (4) ◽

pp. 552-556

Author(s):

Arash Mowla ◽

Mehrnoosh Ghaedsharaf

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Obsessive Compulsive Disorder ◽

Controlled Clinical Trial ◽

Obsessive Compulsive ◽

Double Blind ◽

Good Tolerability ◽

Double Blind Placebo ◽

Compulsive Disorder ◽

Current Medication

AbstractBackground and objective.Glutamate dysfunction has been shown to be associated with pathophysiology of obsessive–compulsive disorder (OCD). Our objective is to survey the effects of pregabalin (a glutamate-modulating agent) as an augmenting treatment for resistant OCD.Patients and methods.In this 12-week double-blind placebo-controlled clinical trial, 56 patients with resistant OCD were randomly allocated to receive either pregabalin or placebo plus their current medication (sertraline). Yale–Brown Obsessive Compulsive Scale (Y-BOCS) was used to evaluate the outcomes. Adverse effects were also registered.Results.Of the 56 patients with resistant OCD who were randomly allocated in 2 groups of pregabalin (n = 28) and placebo group (n = 28), 42 patients (22 in pregabalin group and 20 in placebo group) completed the trial. Throughout the trial, the mean score decreased from 26.13± 7.03 to 8.81 ± 3.47 in the pregabalin group (p < 0) and from 26.85 ± 4.34 to 17.63 ± 4.22 in the placebo group (p < 0). At the end of trial, 16 (57.14%) patients in the pregabalin group and 2 (7.14%) patients in the placebo group showed more than 35% decline in YBOCS (p < .01). The pregabalin group showed good tolerability and safety.Conclusions.Our study revealed that pregabalin, as an augmenting medication, is more effective than placebo in the treatment of patients with resistant OCD.

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Ondansetron Augmentation for Treatment-Resistant Obsessive-Compulsive Disorder: A Randomized Placebo-Controlled Clinical Trial

Iranian Red Crescent Medical Journal ◽

10.5812/ircmj.100918 ◽

2020 ◽

Vol 22 (5) ◽

Author(s):

Zahra Sepehrmanesh ◽

Mehdi Adel ◽

Afshin Ahmadvand ◽

Mojtaba Sehat

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Obsessive Compulsive Disorder ◽

Selective Serotonin Reuptake Inhibitors ◽

Controlled Clinical Trial ◽

Obsessive Compulsive ◽

Double Blind ◽

Compulsive Disorder ◽

First Line Therapy ◽

Significant Difference

Background: Serotonin and dopamine are involved in the development of obsessive-compulsive disorder (OCD). Approximately 40% of OCD patients do not respond to the first-line therapy of treatment using selective serotonin reuptake inhibitors. Reportedly, the response to the treatment is increased by enhancing dopamine blockers. Objectives: The purpose of this study was to evaluate the efficacy and immunogenicity of ondansetron as a booster in the treatment of OCD patients. Methods: The present double-blind, randomized clinical trial (RCT) was conducted on 40 patients (16 males and 24 females) aged 18 to 60 years who met the DSM-V-TR-based OCD diagnostic criteria and had a minimum score of 16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The patients were randomized to receive standard treatment and ondansetron (8 mg/day) or placebo for 12 weeks. They were examined using Y-BOCS and side-effect checklist at baseline, fourth, eighth, and twelfth weeks. Results: The patients in both groups were homogeneous and comparable in terms of age, marital sex status, type of obsession, anxiety, depression, age at the onset of disease, and the duration of disease. The Y-BOCS scores in the intervention and placebo groups were 27.15 ± 3.94 vs. 26.15 ± 4.94 at baseline, 25.40 ± 3.75 vs. 25.00 ± 4.79 in the fourth week, 20.85 ± 3.69 vs. 24.05 ± 4.97 (P = 0.026) in the eighth week, and 17.95 ± 3.43 vs. 21.65 ± 4.85 (P = 0.008) in the twelfth week, respectively. Significant changes occurred between the two groups at weeks 8 and 12; the difference between the two groups was significant (P = 0.015), whereas no significant difference was observed between the two groups before week 8. Conclusions: This 12-week, double-blind, and randomized clinical trial showed that ondansetron was a booster agent with a significant effect on patients with moderate to severe OCD. This study also showed that ondansetron is generally well tolerated by OCD patients. The response to the treatment also increased from the eighth week of treatment onwards. The severity of the disease was decreased at the end of the ondansetron intervention. The adjunct ondansetron treatment was recommended for OCD patients

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Effect of selenium as an adjunctive therapy in patients with treatment-resistant obsessive-compulsive disorder: A pilot randomized double blind placebo-controlled clinical trial

Archives of Psychiatry and Psychotherapy ◽

10.12740/app/99584 ◽

2018 ◽

Vol 20 (4) ◽

pp. 57-65 ◽

Cited By ~ 1

Author(s):

mehdi Sayyah ◽

Mina Andishmand ◽

Reza Ganji

Keyword(s):

Clinical Trial ◽

Obsessive Compulsive Disorder ◽

Adjunctive Therapy ◽

Controlled Clinical Trial ◽

Treatment Resistant ◽

Obsessive Compulsive ◽

Double Blind ◽

Double Blind Placebo ◽

Compulsive Disorder

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Memantine Augmentation of Sertraline in Severity of Symptoms and Cognitive Function Among Patients with Obsessive-Compulsive Disorder: A Double-Blind Placebo-Controlled, Randomized Clinical Trial

10.21203/rs.3.rs-647493/v1 ◽

2021 ◽

Author(s):

Sanaz Askari ◽

Saba Mokhtari ◽

Seyed Vahid Shariat ◽

Behnam Shariati ◽

Masoomeh Yarahmadi ◽

...

Keyword(s):

Clinical Trial ◽

Cognitive Function ◽

Obsessive Compulsive Disorder ◽

Wisconsin Card Sorting Test ◽

P Value ◽

Card Sorting ◽

Obsessive Compulsive ◽

Double Blind ◽

Compulsive Disorder ◽

Significant Difference

Abstract Background: Medications currently recommended for the treatment of Obsessive-Compulsive Disorder (OCD) usually decrease the severity of the symptoms by 20–30%, and 40–60% of OCD patients do not achieve satisfactory treatment. In this study, the main objective was to investigate the effectiveness of memantine, which is a non-competitive N-Methyl-D-aspartate (NMDA) receptor antagonist, as an adjunct therapy to sertraline, a selective serotonin reuptake inhibitor (SSRI), to improve severity of symptoms and cognitive function among patients with obsessive-compulsive disorder. Methods: 70 patients who based on Diagnostic and Statistical Manual of Mental Disorders (DSM–5) criteria were diagnosed with OCD, and had a Yale-Brown obsessive compulsive scale (Y-BOCS) score of more than 21, were recruited in a placebo controlled, double-blinded, parallel-group, clinical trial of 12 weeks to receive either memantine (10 mg twice daily) and sertraline (100 mg daily initially followed by 200 mg daily after week 4) or placebo and sertraline. The primary outcome was OCD symptoms measured by the Y-BOCS, moreover, the executive function and the cognition of participants was measured by the Wisconsin Card Sorting Test (WCST).Results: Y-BOCS score in total, obsession and compulsion subscales significantly dropped in both groups; however, there was not a significant difference between them. In comparison of cognition, memantine group showed a greater response in number of categories subscale in the WCST (p value<0.001). No major adverse effects were observed in any of the groups. Conclusion: Our findings suggest a probable effect of memantine as adjuvant therapy to sertraline on cognitive function of patients with OCD as well as its safety and tolerability in comparison with placebo. Nevertheless, the current results don`t support the efficacy of memantine as an adjunctive agent to sertraline for improving severity of symptoms among patients with OCD.Trial registration: The trial was registered at the Iranian Registry of Clinical Trials on 2019-10-04 (www.irct.ir; IRCT ID: IRCT20170123032145N4).

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Memantine augmentation of sertraline in the treatment of symptoms and executive function among patients with obsessive-compulsive disorder: A double-blind placebo-controlled, randomized clinical trial

BMC Psychiatry ◽

10.1186/s12888-021-03642-z ◽

2022 ◽

Vol 22 (1) ◽

Author(s):

Sanaz Askari ◽

Saba Mokhtari ◽

Seyed Vahid Shariat ◽

Behnam Shariati ◽

Masoomeh Yarahmadi ◽

...

Keyword(s):

Clinical Trial ◽

Executive Function ◽

Obsessive Compulsive Disorder ◽

Wisconsin Card Sorting Test ◽

P Value ◽

Card Sorting ◽

Obsessive Compulsive ◽

Double Blind ◽

Compulsive Disorder ◽

Significant Difference

Abstract Background Medications currently recommended for the treatment of Obsessive-Compulsive Disorder (OCD) usually decrease the severity of the symptoms by 20–30%; however, 40–60% of OCD patients do not achieve a satisfactory response. Our main objective was to investigate the effectiveness of memantine, a non-competitive N-Methyl-D-aspartate (NMDA) receptor antagonist, as an adjunct therapy to sertraline, a selective serotonin reuptake inhibitor (SSRI), to improve severity of symptoms and executive function among patients with obsessive-compulsive disorder. Methods Seventy patients with OCD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM–5) criteria, and a Yale-Brown obsessive compulsive scale (Y-BOCS) score of more than 21 were recruited to the study. They received sertraline (100 mg daily initially followed by 200 mg daily after week 4) and either memantine (10 mg twice daily) or placebo in a placebo controlled, double-blinded, parallel-group, clinical trial of 12 weeks. The primary outcome was OCD symptoms measured by the Y-BOCS. Moreover, executive function of participants was measured by the Wisconsin Card Sorting Test (WCST). Results The total score, and obsession and compulsion subscales of Y-BOCS significantly dropped in both groups with no significant difference between the two groups. However, memantine group showed a greater response in the number of completed categories subscale of the WCST (p value<0.001). We did not observe any major adverse effects in any of the groups. Conclusion Memantine has an acceptable safety and tolerability in patients with OCD and might have a positive effect on their executive function. Nevertheless, the current results don`t support the efficacy of memantine as an adjunctive agent to sertraline for symptoms in patients with OCD. Trial registration The trial was registered at the Iranian Registry of Clinical Trials on 04/10/2019 (www.irct.ir; IRCT ID: IRCT20170123032145N4).

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Duloxetine augmentation in resistant obsessive compulsive disorder: Surveying a new medication for challenges in treatment of OCD

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.361 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S415-S415

Author(s):

A. Mowla

Keyword(s):

Obsessive Compulsive Disorder ◽

Primary Outcome Measure ◽

Controlled Clinical Trial ◽

Double Blind Study ◽

Obsessive Compulsive ◽

Double Blind ◽

Compulsive Disorder ◽

Significant Difference ◽

Competing Interest ◽

To Receive

IntroductionUp to 50% of patients with OCD have failed to respond in SSRI trials, so looking for pharmacological alternatives in treatment of obsessive compulsive disorder (OCD) seems necessary.ObjectivesSurveying duloxetine augmentation in treatment of resistant OCD.AimsStudy the effects of serotonin-norepinephrine enhancers for treatment of OCD.MethodsThis augmentation trial was designed as an 8-week randomized controlled, double blind study. Forty-six patients suffering from OCD who had failed to respond to at least 12 weeks of treatment with a selective serotonin reuptake inhibitor (fluoxetine, citalopram or fluvoxamine) were randomly allocated to receive duloxetine or sertraline plus their current anti OCD treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was the primary outcome measure.ResultsForty-six patients (24 of 30 in duloxetine group and 22 of 27 in sertraline group) completed the trial. Both groups showed improvement over the 8-week study period (mean Y-BOCS total score at week 8 as compared with baseline: P < 0.001 and P < 0.001) without significant difference (P = 0.861). Those receiving duloxetine plus their initial medications experienced a mean decrease of 33.0% in Y-BOCS score and the patients with sertraline added to their initial medication experienced a mean decrease of 34.5% in Y-BOCS.ConclusionsOur double blind controlled clinical trial showed duloxetine to be as effective as sertraline in reducing obsessive and compulsive symptoms in resistant OCD patients. However, it needs to be noted that our study is preliminary and larger double blind placebo controlled studies are necessary to confirm the results.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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