SMRI - Completed Studies

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Principal Investigator in The Following Studies

  • A Phase III, Randomized, Placebo-Controlled, Double-Blind Study of Edivoxetine Flexible-Dose 12mg to 18mg Once Daily and Edivoxetine Fixed-Dose 6mg Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment.
  • A 12-week, Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripripazole Intramuscular Depot in the Acute Treatment of Adults With Schizophrenia (Followed by Open-Label Rollover).
  • A Phase III, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150mg/day) as Adjunctive Therapy in Adults with Major Depression Associated with Bipolar I Disorder (Followed by Open-Label Rollover).
  • A Phase III Study of an Atypical Antipsychotic for Cognitive Symptoms in the Treatment of Patients with Mild to Moderate Alzheimer’s Disease without Psychosis.
  • A Phase IV Head to Head Study of two Atypical Antipsychotics in the Treatment of Patients with Schizophrenia.
  • A Phase III Study on SB-659746 and Citalopram versus Placebo in the Treatment of Patients with Major Depressive Disorder.
  • A Phase III Study on LY544344 versus Placebo in the Treatment of Patients with Generalized Anxiety Disorder who have Responded to Treatment with LY544344.
  • A Phase III Study of an Atypical Antipsychotic plus SSRI in Combinations Compared to an Atypical Antipsychotic and SSRI Monotherapies in the Treatment of Patients with Treatment Resistant Recurrent Major Depressive Disorder.
  • A Phase IV International Trial to Compare the Cardiovascular Safety of Ziprasidone and Olanzapine in the Treatment of Patients with Schizophrenia.
  • A Phase III Fixed Dose Study on GW597599B or Paroxetine (IR Form) to Placebo in the Treatment of Patients who are Moderately to Severely Depressed with Major Depressive Disorder.
  • An Open-Label Study in the Treatment of Patients with Adult Bipolar I Optimizing Initiation of Therapy Using Administration of Dermatological Precautions and Lamictal Titration Packs.
  • A Phase III Study of Flexible Dose Extended-Release Bupropion Hydrochloride and Placebo in the Treatment of Patients with Major Depressive Disorder Including Symptoms of Decreased Energy, Pleasure, and Interest.
  • A Phase II Inpatient Study, Open Label Oral Run-In with an Atypical Antipsychotic Followed by Decanote Formulation with Two Doses in the Treatment of Patients with Schizophrenia.
  • A Phase III Study of a Serotonin Norepinephrine Reuptake Inhibitor Versus Escitalopram and Placebo in the Treatment of Patients with Major Depression.
  • A Phase III Study of an Atypical Antipsychotic / SSRI Combination Versus Lamotrigine in the Treatment of Patients with Bipolar I Depression.
  • A Phase II Inpatient Study of 3 Fixed Doses of an Extended Release Oral Atypical Antipsychotic and Atypical Antipsychotic, With Open-Label Extension, in the Treatment of Subjects with Schizophrenia.
  • A Phase III Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to a Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in the Treatment of Subjects with Schizophrenia.
  • A Phase IIIB Placebo-Controlled Study of an Atypical Antipsychotic in the Treatment of Patients with Bipolar I Disorder with a Major Depressive Episode.
  • A Phase III Placebo-Controlled Study to evaluate the efficacy and safety of Non Benzodiazepine GABA a receptor modulator in patients with Generalized Anxiety Disorder.
  • A Phase III Placebo-Controlled relapse prevention study, with an open-label acute therapy phase and double blind continuation using 3 flexible doses of a Serotonin Norepinephrine Reuptake in patients with Generalized Anxiety Disorder.
  • A Phase IIIB, double-blind, placebo controlled study comparing the efficacy and safety of a Serotonin Norepinephrine Reuptake Inhibitor and placebo for the treatment of recurrent Major Depressive Disorder.
  • A randomized, crossover study to evaluate the overall safety and tolerability of an atypical antipsychotic medication injected in the deltoid or gluteus muscle in subjects with Schizophrenia
  • To assess the efficacy of a Serotonin Norepinephrine Reuptake Inhibitor compared with placebo on the reduction of pain in patients with Fibromyalgia Syndrome with or without Major Depressive Disorder as defined by the American College of Rheumatology.
  • An open-label evaluation of the safety of an anticholinesterase medication in patients with moderate-to-severe Dementia of the Alzheimer’s Type.
  • A Phase IV open-label, parallel design trial to compare time to Response in the symptoms of anxiety to concomitant treatment with a Benzodiazepine and an SSRI or SNRI to treatment with an SSRI or SNRI alone in subjects with Generalized Anxiety Disorder or Panic Disorder.
  • A Phase IIIB Placebo-Controlled Study of an Atypical Antipsychotic in the Treatment of Patients with Bipolar I Disorder with a Major Depressive Episode.
  • A Phase II, Double Blind, Randomized, Placebo-Controlled Study of Efficacy, Safety and Tolerability of a Melatonin Agonist in Sleep Disturbed, Community Dwelling, Mild to Moderately Severe Alzheimer ’s Disease Subjects.
  • A Phase III, Double Blind, Randomized, Placebo-Controlled Study of an Atypical Antipsychotic Used as Dual Therapy in the Treatment of Patients with Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to an Antipsychotic Monotherapy
  • A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Investigate the Effects of a PPARy Agonist as Adjunctive Therapy to a Cholinesterase Inhibitor on Cognition and Overall Clinical Response in APOE 4-Stratified Subjects with Mild to Moderate Alzheimer’s Disease.
  • A Phase III , Double-Blind, Placebo controlled using two Antipsychotics in the treatment of Bipolar I Disorder, Mixed Episode.
  • A Phase III , Double-Blind, Placebo and an SSRI controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of a New Medication in Patients with Major Depressive Disorder.
  • A Phase III , Double-Blind, Placebo and an SSRI controlled Study Evaluating the Efficacy and Tolerabilty of Two Fixed Doses of a New Medication in Patients with Generalized Anxiety Disorder.
  • A Phase II, double blind parallel arm study comparing LY2216684 with Placebo and SSRI in patients with Major Depressive Disorder.
  • A Phase II, Double- Blind, Placebo and SSRI controlled Study Evaluating the Efficacy and Tolerability of a Selective NERI in the Treatment of Major Depression.
  • A Phase III, Double-Blind, Placebo Controlled, Parallel-Group, Evaluating the Efficacy and Safety of (AAB-001) in Patients with Mild to Moderate Alzheimer's Disease.
  • A Phase I, Exploratory, Non Drug,Interventional Study to Determine Whether the Interactive Voice Response Version (IVR) Arizona Sexual Experience Scale (ASEX) is a Psychometrically Valid Version of the Original(Paper) Scale in Patients with Major Depression, in Remission.
  • A Phase IIIb, Double-Blind, Doubly-Dummy, Placebo-Controlled Study Designed to Evaluate a Combination of Sumatripan Succinate and Naproxen Sodium Compared to a BCM for the Treatment of Acute Migraines.
  • A Phase IV, Open Label, Active Comparator, Parallel Group Trial for the Evaluation of an SNRI Versus Generic SSRIs in the Treatment of Patients with Severe Baseline Symptoms of Major Depressive Disorder.
  • A Phase III, Randomized, Double Blind, Parallel-Group,Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of a Single Dose of a 5HT1A and 5HT3 Agonist in Acute Treatment of Adults with Generalized Anxiety Disorder.
  • A Phase III, Placebo Controlled, Randomized Withdrawal Study.Maintenance of Response After Open-Label Treatment with a Selective Norepinephrine Reuptake Inhibitor (NRI) In Adult Outpatients with Attention Deficit/Hyperactivity Disorder.
  • A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase II Study of 2 Oral Dose Groups of a GABA Receptor Selective Agonist, with a Lorazepam Arm, in Subjects With Generalized Anxiety Disorder.
  • A Phase III, Multicenter, Open-Label Study to Evaluate the Effectiveness of an Atypical Antipsychotic Intramuscular Depotas Maintenance Treatment in Patients with Schizophrenia.(Followed by an Open-Label Rollover)
  • A Phase III, Multicenter, Randomized, Double-Blind Active Control of an SSRI, Parallel-Group Study Assessing the Efficacy and Safety of an Atypical Antipsychotic plus SSRI Combination in the Prevention of Relapse in Patients with Treatment Resistant Depression.
  • A Phase III, Double-Blind Placebo Controlled, Fixed Dose Study of an SNRI in Adult Patients With Major Depressive Disorder (Followed by an Open-Label Rollover)
  • A Phase IV, 8 Week, Double Blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of an SNRI in Outpatients With Major Depressive Disorder and Associated Painful Physical Symptoms.
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel, 12 Week, Phase II Study of Two Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Antagonist or Placebo in Schizophrenia Subjects on Chronic Stable Atypical Anti Psychotic Therapy.
  • A 12 Week, Randomized, Double-Blind, Placebo-Controlled, Phase III Safety Trial of a 5HT1A Agonist and a 5HT2A Antagonist in Women Taking a Selective Serotonin or Serotonin Norepinephrine Reuptake Inhibitor With Decreased Sexual Desire and Distress and Major Depressive Disorder.
  • A Phase III, Randomized, Double Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of a 5-HT3, 5-HT1B and 5-HT7 Receptor Antagonist, 5-HT1A Receptor Agonist and 5-HT Transporter Inhibitor in Acute Treatment of Adults With Major Depressive Disorder (Followed by an Open-Label Rollover)
  • A Phase III, Double-Blind, Placebo Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of a Stimulant as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar Disorder.
  • A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Of 3 doses of a Methionine Prodrug of the Potent mGlu2/3 Receptor Antagonist Monohydrate in the Acute Treatment of Patients With DSM-IV-TR Schizophrenia. Includes a 14 day hospital stay. (Followed by Open-Label Rollover).
  • A Phase III, Multicenter, Double-Blind Comparison of an Methionine Prodrug of the Potent mGlu2/3 Receptor Antagonist and Aripiprazole in Patients with DSM-IV-TR Schizophrenia.
  • A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi- Center Biomarker, Safety, and Pharmacokinetic Study of (AAB-001) Administered Subcutaneously at Monthly Intervals in Subjects with Mild to Moderate Alzheimer Disease.
  • A Phase III, Randomized, Placebo-Controlled, Double-Blind Study of a Norepinephrine Reuptake Inhibitor Flexible Dose Daily and a Norepinephrine Reuptake Inhibitor Fixed Dose Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder who are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment.
  • A Phase IIb, Multicenter, Randomized, Double-Blind, Active Controlled Study of the Efficacy and Safety of Flexibility-Dosed Triple Reuptake Inhibitor in Patients with Treatment Resistant Major Depression (Followed by Open -Label Rollover).
  • A Phase IIb/III, Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Study to Investigate the Safety and Efficacy of Potent Agonist of Melatonin Receptor Versus Placebo in Adult Subjects with Major Depressive Disorder Followed by a 52 Week Open-Label Extension.
  • A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study To Evaluate the Efficacy And Safety of a Stimulants Adjunctive Therapy in Adults with major Depression Associated With Bipolar I Disorder
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of 2 Doses of Alpha-7 NARA or Placebo as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy (Followed by Open-Label Rollover)
  • A Randomized, Double-Blind, Placebo-Controlled Trial of Aripiprazole Intramuscular Depot in the Acute Treatment of Adults with Schizophrenia(Followed by Open-Label Rollover)
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of  LMTM in Subjects with Mild Alzheimer's Disease
  • A Double-Blind, Placebo-Controlled, Flexible- Dose Study of Vilazodone in Patients with Generalized Anxiety Disorder
  • A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study  to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
  • A Phase III, Randomized, Placebo-Controlled, Parallel-Group Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cogntive Impairment Due to Alzheimer's Disease (Prodromal AD)
  • A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine as an Active Control in Subjects With an Acute Exacerbation of Schizophrenia (Phase 3B, Protocol P05688 [formerly 041038])
  • A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine using Olanzapine as an Active Control in Subjects Diagnosed with Schizophrenia who Completed Protocol P05688 (formerly 041038) (Phase 3B, Protocol P05689 [formerly 041039])
  • An Exploratory, Multicenter, Open-label, Flexible-dose Brexpiprazole (OPC-34712) Trial in Adults With Acute Schizophrenia
  • A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) 0.1, 0.4, and 0.8 mg as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated with Bipolar 1 Disorder in Adult Subjects
  • A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375SL 0.1, 0.4, and 0.8 mg as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar 1 Disorder in Adult Subjects
 
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