Efficacy and Safety Study of Escitalopram Augmentation in Treatment Resistant Schizophrenia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||The Efficacy and Safety of Escitalopram Augmentation of Risperidone and Olanzapine in Treatment Resistant Schizophrenia: a Double Blind Placebo Controlled Pilot Study|
- Reduction of severity of symptoms defined as decrease of >20% from baseline to final evaluation on the PANSS total score.
- Changes on depression/anxiety dimensions of PANSS subscales defined as decrease of >20% from baseline to final evaluation.
|Study Start Date:||March 2006|
|Study Completion Date:||July 2007|
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.