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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR MOCLOBEMIDE

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Clinical Trials for Moclobemide

Trial ID Title Status Sponsor Phase Summary
NCT00534573 Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation Completed Tirat Carmel Mental Health Center Phase 3 Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy, and until now there is not enough effective treatment for this side effect leading to noncompliance. In previous studies it was found that substitute benzamide derivatives with higher selective binding to the D2/D3 dopamine receptor - amisulpride and sulpiride may be effective in treatment of clozapine-induced hypersalivation (CIH). Today, in psychiatric practice in Israel, there are four medications which belong to substitute benzamide derivatives group: amisulpride, sulpiride, tiapride and moclobemide. We hypothesized that antisalivation effect is universal for the whole group of benzamide. The aim of our study was to compare efficacy of amisulpride, moclobemide (reversible monoamine oxidase inhibitor-A (RIMAS)), and tiapride (dopamine D2 antagonist) as an additional possibility for management of CIH.
NCT00534573 Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation Completed Beersheva Mental Health Center Phase 3 Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy, and until now there is not enough effective treatment for this side effect leading to noncompliance. In previous studies it was found that substitute benzamide derivatives with higher selective binding to the D2/D3 dopamine receptor - amisulpride and sulpiride may be effective in treatment of clozapine-induced hypersalivation (CIH). Today, in psychiatric practice in Israel, there are four medications which belong to substitute benzamide derivatives group: amisulpride, sulpiride, tiapride and moclobemide. We hypothesized that antisalivation effect is universal for the whole group of benzamide. The aim of our study was to compare efficacy of amisulpride, moclobemide (reversible monoamine oxidase inhibitor-A (RIMAS)), and tiapride (dopamine D2 antagonist) as an additional possibility for management of CIH.
NCT00610506 Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features Completed Forest Laboratories Phase 3 Aims of Study: The aims of this study are 1) to examine the clinical utility of escitalopram in patients with major depression with atypical features; 2) to evaluate the tolerability of escitalopram in major depression with atypical features. Study hypothesis and objectives. This study is proposed as an open-label study to gather pilot data to examine whether escitalopram has clinical utility in the treatment of major depression with atypical features. Because of the exploratory nature of the design, no specific study hypotheses can be generated regarding efficacy of the drug. Our primary hypothesis is that the effect size of escitalopram in atypical depression will be similar to the effect size of escitalopram in major depression, its FDA approved indication.
NCT00610506 Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features Completed Duke University Phase 3 Aims of Study: The aims of this study are 1) to examine the clinical utility of escitalopram in patients with major depression with atypical features; 2) to evaluate the tolerability of escitalopram in major depression with atypical features. Study hypothesis and objectives. This study is proposed as an open-label study to gather pilot data to examine whether escitalopram has clinical utility in the treatment of major depression with atypical features. Because of the exploratory nature of the design, no specific study hypotheses can be generated regarding efficacy of the drug. Our primary hypothesis is that the effect size of escitalopram in atypical depression will be similar to the effect size of escitalopram in major depression, its FDA approved indication.
NCT01926626 Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers Completed National Institute on Drug Abuse (NIDA) Phase 2 The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This rationale is based on several findings from previous work: 1) cigarette smoke contains constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2) that severity of depression symptoms after smoking abstinence is correlated with the level of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women show a greater association between smoking and depression than men and women smokers in our previous trials report smoking to alleviate symptoms of depression to a greater extent than men.
NCT01926626 Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers Completed Philip Morris USA, Inc. Phase 2 The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This rationale is based on several findings from previous work: 1) cigarette smoke contains constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2) that severity of depression symptoms after smoking abstinence is correlated with the level of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women show a greater association between smoking and depression than men and women smokers in our previous trials report smoking to alleviate symptoms of depression to a greater extent than men.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Moclobemide

Condition Name

Condition Name for
Intervention Trials
Clozapine-induced Hypersalivation 2
Anxiety Disorders 1
Psychosomatic Disorders 1
Addiction 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Sialorrhea 2
Anxiety Disorders 1
Tobacco Use Disorder 1
Behavior, Addictive 1
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Clinical Trial Locations for Moclobemide

Trials by Country

Trials by Country for
Location Trials
United States 2
Israel 2
Germany 1
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Trials by US State

Trials by US State for
Location Trials
North Carolina 2
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Clinical Trial Progress for Moclobemide

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 4
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 4
Active, not recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Moclobemide

Sponsor Name

Sponsor Name for
Sponsor Trials
Beersheva Mental Health Center 2
Tirat Carmel Mental Health Center 2
Philip Morris USA, Inc. 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 8
Industry 2
NIH 1
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