Clinical Trials

Experience

International Multicentric studies

  • Otsuka (APEX Studies) Protocol 31-03-239

    A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Two Fixed Oral Doses of Aripiprazole (10 mg or 30 mg) in the Treatment of Adolescent Patients with Schizophrenia.

  • Otsuka (APEX Studies) Protocol No. 31.03.241

    A Multi-center, open-label, Safety and Tolerability study of flexible-dose oral Aripiprazole (2mg – 30mg) in the treatment of adolescent patients with Schizophrenia, and Child and Adolescent patients with Bipolar I Disorder, Manic or Mixed Episode with or without psychotic features.

  • Protocol No. 31.05.243: “An Open-Label Rollover Study for Subjects with Schizophrenia Completing ABILIFY (Aripiprazole) Clinical Study 31-03-241”.

  • PFIZER INC. & ORGANON IRELAND LTD.

    A7501008 titled “A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode.”

  • Study A7501009

    Study A7501009 titled “A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing Trial A7501008 and continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode.”

  • ZIPRASIDONE – Protocol No – A1281137

    “A Phase 3, Randomized, 6-Month, Double Blind Trial in Subjects with Bipolar I Disorder to evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (Vs Placebo Plus a Mood Stabilizer) following a Minimum of 2 months of Response to open-Label Treatment with both agents.”

  • Protocol # F02695 LP 202

    A double blind, multinational, multicentre, placebo-controlled 10-week study assessing the efficacy and safety of F2695 SR flexible dose (75,100 mg /day) in the treatment of patients with Major Depressive Disorder.

  • Protocol No LY2216684 : Protocol: H9P-MC-LNBD:

    A Study of the Effects of LY2216684, a Selective Norepinephrine Reuptake Inhibitor (NERI), in the Treatment of Major Depression.

  • Targacept Inc. through QED Pharmaceuticals Protocol TC-5214-23-CRD-001

    A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Flexible Dose Titration, Add-On Study of TC-5214 2 – 8 mg in the Treatment of Major Depressive Disorder with Subjects who are Partial Responders or Non-Responders to Citalopram Therapy.

  • Dainippon Sumitomo Pharma (DSP) Protocol Number D1050231 (Pearl 2):

    A Phase 3, Randomized, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Two doses of Lurasidone HCl in Acutely Psychotic Patients with Schizophrenia.

  • Dainippon Sumitomo Pharma (DSP) Protocol Number D1050233:

    A Phase 3 Randomized, Double Blind ,Placebo-And Active Controlled Clinical Trial to Study the Efficacy & Safety of Two Doses of Lurasidone in Acutely Psychotic Patients with Schizophrenia (Pearl 3)

  • Dainippon Sumitomo Pharma (DSP) Protocol Number D1050234:

    A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (Pearl 3 Extension Study)

  • Forest Research Institute Protocol RGH – MD – 16

    Evaluation of the safety and efficacy of RCH – 188 in the acute exacerbation of schizophrenia.

  • Protocol RGH – MD – 17

    A long term, Open Label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients with Schizophrenia.

  • Protocol RGH – MD – 32

    A Double Blind, Placebo Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients with Acute Mania Associated with Bipolar I disorder.

  • Zoom Clinical Trials – QED Pharmaceuticals Pvt. Ltd. PRO-05619-CRD-001

    A Double-Blind, PlACEBO-Controlled, Multicenter, Parallel Group Study to Assess Efficacy ,Safety and Tolerability of TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients with Cognitive Dysfunction in Schizophrenia.

  • Zoom Clinical Trials – QED Pharmaceuticals Pvt. Ltd. PRO-05619-CRD-001

    A Double-Blind, PlACEBO-Controlled, Multicenter, Parallel Group Study to Assess Efficacy ,Safety and Tolerability of TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients with Cognitive Dysfunction in Schizophrenia.

  • Protocol RGH MD 05

    A Double – Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia.

  • Protocol RGH MD 11

    Evaluation of the Long-term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients with Schizophrenia.

  • Study No. 09-23

    A randomized, double blind, placebo controlled, multicentric study to assess the efficacy and safety of Udenafil tablets in patients suffering from erectile dysfunction

  • AstraZeneca Protocol No.: D4130C00004 (Fixed)

    A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy.

  • Protocol No. D4130C00002 (Flex):

    A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy.

  • Covance ACES Study: Protocol No 31-08-255

    A Multicentric, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole / Escitalopram Combination Therapy in Patients with Major Depressive Disorder.

  • Covance ACES Study: Protocol No 31-08-257

    A Multicenter, 52-week, Open-label Study to Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients with Major Depressive Disorder.

  • I3 Research Institute CL3-20098-074

    Efficacy and safety of agomelatine with flexible dose (25 mg/day with blinded potential adjustment at 50 mg) given orally for 8 weeks in Indian outpatients with Major Depressive Disorder. A randomized double-blind national multicentric study with parallel groups, versus sertraline (50 mg/day with blinded potential adjustment at 100 mg).

  • H6P-MC-HDAY

    A Study to Assess the Long-Term Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Fluoxetine Only in the Relapse Prevention of Stabilized Patients with Treatment-Resistant Depression

  • Covance ACES Study : Protocol 31-09-267

    A Long-term, Multicentric, Open-Label Study to Evaluate the Safety and Tolerability of Flexible – Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients with Schizophrenia or Child and Adolescent Patient with Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features

  • OTSUKA - Protocol no. 31-10-273

    A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-Weekly Oral Aripiprazole in Children and Adolescents with Tourette’s Disorder.

  • OTSUKA - Protocol No, 31-10-274

    An Open-label, Multicenter Study Evaluating the Safety and Tolerability of Once-Weekly Oral Aripiprazole in Children and Adolescents with Tourette’s Disorder.

  • Protocol:1020-CLIN-201

    A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Study to Determine the Short-Term (6-Week) and Long-Term (6 Month) Cognitive and Anti-Psychotic Efficacy, Safety and Tolerability of CYP-1020 Compared to Risperidone in Patients with Schizophrenia

  • Protocol No. R092670-SCA-3004:

    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Paliperidone Palmitate evaluating time to relapse in subjects with Schizoaffective disorder.

  • Protocol Number: Natreon-GAD-02-001 (Clinprax):

    A Phase II Double-Blind, Parallel Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients with Generalized Anxiety Disorder.

  • Protocol FIJ-MC-HMGW:

    Effect of Duloxetine 30/60mg Once Daily versus Placebo in Adolescents with Juvenile Primary Fibromyagia Syndrome.

  • Protocol No. P05896

    An 8-week, placebo-controlled, double-blind, randomized, fixed-dose efficacy and safety trial of asenapine in adolescent subjects with schizophreni.

  • Protocol No. P05897

    A 26-week, multi-center, open-label, flexible dose, long-term safety trial of asenapine in adolescent subjects with schizophrenia Phase 3b

  • Protocol No. ILO522D2301:

    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Prevention of Relapse in Patients with Schizophrenia Receiving Either flexible dose Iloperidone (Fanapt™) or Placebo in long term use (up to 26 weeks) followed by up to 52-Weeks of Open-label Extension

  • Protocol No.: 12JNJ029 (83095) Project UNITE:

    A randomized, controlled trial to assess the impact of TAMA (Health IT System) on treatment effectiveness in HIV-1 infected subjects initiated on first-line antiretroviral therapy.

  • Protocol No.: Study 365-15:

    A Double-Blind, Double-Dummy, Active-Controlled, Oral, Multiple-Dose, Parallel, Randomized Study To Evaluate Efficacy And Safety Of Endoxifen In Bipolar I Disorder Patients

  • Protocol Number: TOL3010C:

    A Pivotal, Multiple-dose, Pharmacokinetic Bioequivalence Trial Comparing Generic To Reference Listed Drug Of Paliperidone Palmitate Extended-release Injectable Suspension (156 Mg) In Subjects With Schizophrenia Or Schizoaffective Disorder

  • Protocol ARIS-18036:

    A Randomized, Multicenter, Multiple-dose, Crossover, Steady-state Bioequivalence Study of Aripiprazole Extended Release Injectable Suspension and Abilify Maintena® in Subjects with Schizophrenia.

  • Protocol - 0851-17:

    A randomized, open label, multicenter, parallel group, multiple dose, steady state study to compare the bioavailability and characterize the pharmacokinetic profile of the sponsor’s test formulation [Paliperidone Palmitate extended release injectable suspension, (156 mg/ml)] relative to that of the reference formulation [Invega® Sustenna® (Paliperidone Palmitate extended release injectable suspension, 156 mg/ml), Janssen Pharmaceuticals, Inc., Titusville, New Jersey] and establish bioequivalence in patients of Schizophrenia already receiving a stable regimen of paliperidone palmitate extended release injectable suspension.

  • Protocol No: CBCC/2019/004:

    A two-treatment, single-period, parallel, steady state bioequivalence study of Paliperidone Palmitate injection 156mg/mL

  • Protocol No: 0567-18

    A Multicentric, Open Label, Balanced, Randomized, Two-Period, Twosequence, Crossover, Steady State, Food Effect Study of Clozapine Extended Release Capsule 200 Mg Once Daily (Test Drug, Intas Pharmaceuticals Limited, India) After Multiple Dose Administration in Adult Schizophrenic Patients Under Fasting and Fed Condition

Upcoming Studies:

  • Protocol #C2A00692:

    A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Sequence, Multicenter, Multiple-Dose, Steady-State, Crossover, Bioequivalence Study of Aripiprazole Extended Release Injectable Suspension 400 mg/vial of Sun Pharmaceutical Industries Limited Compared to ABILIFY MAINTENA® 400 mg/vial of Otsuka America Pharmaceutical Inc., USA in Adult Patients with Schizophrenia under Fasting Condition

  • PP1M-GX-101:

    Open-Label, Randomized, Multiple-Dose, Two-Treatment, Parallel Group, Steady State Relative Bioavailability Study of Lupin Paliperidone Palmitate Extended-Release Injectable Suspension 156mg/mL Compared with Invega Sustenna® (Paliperidone Palmitate) Extended-Release Injectable Suspension 156 mg/mL in Adult Male and Female Patients with Schizophrenia

  • PALI-ISR-1002:

    A Randomized, Multicenter, Multiple-dose, Two-treatment, Single period, Parallel, Steady-State Bioequivalence Study of Mylan’s Paliperidone Prolonged-release Suspension for Injection, 350 mg and Janssen-Cilag’s Trevicta ® Prolonged-release Suspension for Injection, 350 mg in Subjects with Schizophrenia.

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