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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
| Göteborg University | OTHER |
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The objective of this study is to explore the onset of action when serotonin reuptake inhibitors are used to treat premenstrual dysphoric disorder
Whereas serotonin reuptake inhibitors (SRIs) usually require weeks of treatment to effectively counteract depressed mood or anxiety, several studies suggest that they may reduce the symptoms irritability and anger more rapidly. In line with this, SRIs have been shown to reduce certain symptoms, including irritability, in women with premenstrual dysphoric disorder (PMDD) when the drug only is administered from ovulation to menstruation only, which indicates an onset of action of 10 days or less. How fast this effect appears in terms of hours or days is, however, not known. The objective of this study was to explore this issue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Paroxetine 20mg during the luteal phase of the menstrual cycle |
|
| 2 | Placebo Comparator | Placebo during the luteal phase of the menstrual cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paroxetine | Drug | Capsules containing either placebo or paroxetine 20 mg. The treatment start after ovulation and when the subject has experienced premenstrual irritability for 2 days. The dosage is one capsule daily at 8 AM |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients reaching sustained remission (irritability) for each time point |
| Measure | Description | Time Frame |
|---|---|---|
| Self rated irritability at each time point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikael SG Landen, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Psychiatric clinic, Sahlgrenska University Hospital | Gothenburg | SE43180 | Sweden |
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| ID | Term |
|---|---|
| D065446 | Premenstrual Dysphoric Disorder |
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003866 | Depressive Disorder |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D019964 | Mood Disorders |
| D001523 | Mental Disorders |