CTRI/2012/01/002315
Not Yet Recruiting
Phase 3
Comparative Evaluation of Efficacy and Safety of Clonazepam-CR and Conventional Clonazepam in Patients with Panic Disorder.
Ipca Laboratories Ltd Mumbai0 sites232 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients with panic disorder with or without agoraphobia, as diagnosed by structured clinical interview for DSM-IV-TR
- Sponsor
- Ipca Laboratories Ltd Mumbai
- Enrollment
- 232
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General Health
- •\-Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition
- •Conditions under study
- •\-Patients meeting the DSM\-IV\-TR criteria for panic disorder with or without agoraphobia, as diagnosed by structured clinical interview for DSM\-IV\-TR
- •\-Patients who have experienced at least 4 panic attacks during 4 weeks preceding screening visit
- •\-Patients having at\-least 1 panic attack during 1\-week placebo period
- •\-Patients with Clinical global impressions of severity (CGI\-S) score for panic disorder of at least 4\.
- •\-Patients with co\-morbid major depressive disorder may be included provided that the onset of panic disorder was earlier than the onset of the depressive disorder.
- •\-Patient and LAR (if required) must understand and be able, willing and likely to fully comply with study procedures and restrictions.
- •\-Patients who are willing to adhere to visit schedule and keep record of panic attack details in diaries during the entire study period
Exclusion Criteria
- •Conditions under study
- •\-Any current physical or mental condition that would limit ability to complete the study, increase the patientâ??s risk, or obscure efficacy measures
- •\-Primary diagnosis of major depression, dysthymia, social phobia, or generalized anxiety disorder
- •\-Patients with or history of organic mental disorder, schizophrenia, bipolar disorder, or obsessive compulsive disorder
- •\-Patients with score of 18 on the Hamilton Rating Scale for Depression (HAM\-D)
- •\-Patients who are currently at high risk for homicide or suicide
- •\-Patients with current or history of post\-traumatic stress disorder including epilepsy, meningitis, parkinsonism or risk of respiratory depression
- •Concurrent disease
- •\-Patients with abnormal ECG, recent or history of cardiovascular accident
- •\-Patients who are known case of uncontrolled narrow\-angle glaucoma
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not Yet Recruiting
Phase 4
Microneedling with topical autologous Platelet rich plasma versus intralesional Triamcinolone acetonide in Alopecia AreataCTRI/2021/03/031963Dr Surabhi Dayal
Not Yet Recruiting
N/A
CAL(Cell assisted lipo-transfer) in treating recurrent complex anal fistulaKCT0008334Hangun Hospital Bumcheon Campus20
Active, Not Recruiting
Phase 1
An evaluation of the safety and effectiveness of combination therapy using the thiazolidinedione pioglitazone alongside insulin in type 2 diabetes mellitus.EUCTR2006-001982-41-GBBradford Teaching Hospitals NHS Foundation Trust40
Not Yet Recruiting
Phase 3
Clinical trial to study the effect of a combination of propolis, vitamin C and vitamin E on the wound healing after wisdom tooth surgery.Health Condition 1: K011- Impacted teethCTRI/2020/06/026019DR KARISHMA MOTWANI
Completed
Phase 2
A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse.Diffuse large B-cell lymphomaJPRN-UMIN000013540Department of Hematology and Oncology, Osaka University Graduate School of Medicine100