Clinical Trials

 

Clinical trials: International Multicentric studies

 

Completed Studies

 

1. 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.

 

2. 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.

 

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

 

4. 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 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.”

 

5. 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.”

 

 6. 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.

 

 7. Eli Lilly and company, Indianapolis, Indiana USA. 46285

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.

 

8. 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.

 

9. 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.

 

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) 

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)

 

10. Forest Research Institute

Protocol RGH – MD – 16:  Evaluation of the safety and efficacy of RCH – 188 in the acute exacerbation of schizophrenia.

 

 11. Protocol RGH – MD – 17: A long term, Open Label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients with Schizophrenia.

 

12. 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.

 

13. 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.

 

14. 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.

 

15. 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

 

16. 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

 

17. 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.

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.

 

 18. 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).

 

19. 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”.

 

20. 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.

 

21. 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.

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.

 

22. 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

 

23. 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.

 

24. 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.

 

25.Protocol FIJ-MC-HMGW: Effect of Duloxetine 30/60mg Once Daily versus Placebo in Adolescents with Juvenile Primary Fibromyagia Syndrome.

 

26. Protocol No. P05896

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

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;

 

27. 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

 

28. 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.

 

CURRENT STUDIES

29.  Protocol No.: CR107-15: A Multicentric, Open Label, Randomized, Two-Treatment, Two-sequence, Two-period, Cross-over, Steady-state Clinical Bioequivalence Study of Quetiapine 400 mg prolonged-release tablets of Krka, d. d., Slovenia., EU (Test) with Seroquel XR®400 mg prolonged-release tablets (quetiapine) of AstraZeneca BV (Reference) in Adult Schizophrenic Patients who Already Receiving Quetiapine 400 mg Under Fasting Conditions.