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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
A primary hypothesis to be explored here is that, given its pharmacodynamic profile and hypothesized mechanisms associated with schizophrenia, escitalopram will, in comparison to placebo, be effective when added to risperidone or olanzapine treated group in reducing the severity of resistant symptoms, particularly existing subsyndromal anxiety and depression.
The objective of this trial is to determine the efficacy and safety of augmenting risperidone or olanzapine with escitalopram for treatment of symptoms of schizophrenia in patients with incomplete response to adequate trials of either of the two antipsychotic medications. To our knowledge, this is the first double blind randomized study designed to examine the potential augmentation benefit of escitalopram combined with a commonly used atypical agent in chronic schizophrenic patients with incomplete response to risperidone or olanzapine. The current proposal offers the possibility to test the efficacy of augmentation treatment in a controlled fashion with clinical and biological variables used as indicators of response and tolerability. From a broader perspective, it would test the hypothesis of potential validity of SSRI augmentation strategy in treatment of resistant symptoms of schizophrenia.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of severity of symptoms defined as decrease of >20% from baseline to final evaluation on the PANSS total score. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on depression/anxiety dimensions of PANSS subscales defined as decrease of >20% from baseline to final evaluation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dragan Bugarski-Kirola, MD | Emory University | Principal Investigator |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |