Principal investigator

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  • 1. 2001-2013 Participated in the following studies as Principal Investigator Novartis AGO. “An 8 week, multicenter, randomized, double blind, placebo and paroxetine study of the efficacy, safety and tolerability of agomelatine 25 or 50 mg given once daily in the treatment of Major Depressive Disorder (MDD) followed by a 28 week open label treatment with agomelatin 25 or 50 mg.” Eisai ALF. “A 12 week Multi Center OPEN Label , Place study to evaluate the effectiveness and safety of Donepezil (Aricept) in Mild to Severe Alzheimers Disease residing in Assisted Living Facility.” A multicenter, double-blind, randomized, parallel group, active-controlled tolerability and safety study of MK-3756 (SM-13496/Lurasidone) in clinically stable schizophrenic outpatients (Merck: Protocol 021- 00) “A randomized, double-blind, placebo-controlled and olanzapine-referenced, parallel-group efficacy and safety study of two fixed doses of bifeprunox in the treatment of schizophrenia.” (Solvay/ Protocol S1543003/004/005) “A six-week, double-blind, multicenter, placebo-controlled study evaluating the efficacy and safety of flexible doses of oral ziprasidone in outpatients with bipolar I depression.” (Pfizer/ Protocol A1281139) “A randomized, double-blind, placebo-controlled, efficacy, safety, and tolerability study of bifeprunox in the treatment of elderly subjects with psychosis and behavioral disturbances associated with dementia of the Alzheimer’s Type.” (Solvay /Protocol S1543016). “Phase III Multicenter, randomized, double-blind placebo-controlled study of the effect of daily treatment with MPC-7869 on measures of cognition, activities of daily living, and global
  • 2. function in subjects with mild dementia of the Alzheimer’s type.” (Myriad / Protocol MPC-7869-04- 005.03). “A Multicenter, randomized, double-blind, parallel-group, fixed-dose study of the effect on weight of bifeprenox versus olanzapine in the treatment of outpatients with schizophrenia.”(Wyeth/Protocol 3168A1-311). A Multicenter, randomized, double-blind, parallel-group, fixed-dose study of the effect on weight of bifeprenox versus risperidone in the treatment of outpatients with schizophrenia.”(Wyeth/Protocol 3168A1-313). An open-label extension study to evaluate the long-term safety and Tolerability OfBifeprunox in the treatment of outpatients with Schizophrenia (Wyeth 3168A1-312, 314) A Randomized, Multicenter, Double-blind, Parallel Group Study to Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenia Patients. (Solvay/ Protocol S154.3.021-Subinvestigator) A multi-center, openl label, parallel group, randomized, flexible dose study to evaluate the safety and tolerability of switching from existing atypical antipsychotics to bifeprunox in subjects with schizophrenia or schizoaffective disorder ( Solvay/Protocol S154.3.020-Subinvestigator) A multicenter, open-label, flexible-dose, parallel-group evaluation of the cataractogenic potential of quetiapinefumarate (SEROQUEL TM) and
  • 3. risperidone (RISPERDAL TM) in the long-term treatment of patients with schizophrenia or schizoaffective disorder (Protocol 5077IL/0089/ AztraZeneca) A Four-Week Double Blind Multi-Center Study Comparing the Efficacy and Safety of the Ziprasidone to Aripiprazole in Subjects With Schizophrenia or Schizoaffective Disorder Needing Inpatient Care. (Sub investigator/Rater). Supported by Pfizer. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With An Open-Label Extension Evaluating Extended Release OROS® Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia: Protocol: R076477-SCH-301 Extension Protocol: R076477-SCH-701. (Sub-investigator/Rater). Supported by Johnson & Johnson. Zodiac Study. An International, Multicenter Large Simple Trial (LST) to Compare the Cardiovascular Safety of Ziprasidone and Olanzapine. (Principal Investigator).Supported by Pfizer. Janssen RIS-OUT-173.“A prospective 2 year observational study of patients with schizophrenia, who initiate treatment with RISPERDAL CONSTA.” Use of Depakote on agitated dementias. (Principal Investigator). Supported by Abbot. Use of Reminyl in Lewy Body Dementia.(Principal Investigator).
  • 4. Supported by Jenssen. Use of Aricept in dementia of Alzheimer type.(Coordinator during Residency) 2002. A 48-Week, Multicenter, Randomized, Double-blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability Of Exelon 10 and 15 cm2 Patch in Patients with Alzheimer’s Disease Showing Cognitive Decline during an Initial Open-Label TreatmentPhase (Protocol No. CENA713D2340/Novartis). A Randomized, Placebo-Controlled, Double-blind, Parallel Group Phase II b Study of AZD 340 in the Treatment of Cognitive Deficits In Patients with Schizophrenia (Protocol No D3690C00011/AztraZeneca) DSP Schizophrenia LTSS “Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects with Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial” Protocol No. D1050237 DSP Alzheimer’s study “A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose- Ranging Study Assessing the Efficacy and Safety of AC-3933 Tablets Twice Daily in Adults with Mild to Moderate Alzheimer’s Disease” Sanofi Aventis "A 24 Week, Multicenter, Double-Blind, Randomized, Parallel- Group, Dose Ranging Study of the Efficacy and Safety of oral doses of AVE 1625 5, 10, and 30 mg and placebo on top of an established treatment regimen of either olanzapine, risperidone/paliperidone,quetiapine or aripiprazolemonotherapy in the treatment of Cognitive Impairment in Schizophrenia"
  • 5. A52-week,Multicenter,Open-labelStudyto Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients with Schizophrenia “ASPIRE OPEN-LABEL” (Aripiprazole Intramuscular Depot Program in Schizophrenia) A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active- Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of LuAA21004 in Acute Treatment of Adults with Generalized Anxiety Disorder. (Takeda Global Research)