Clonazepam-CR in Patients with Panic Disorder
- Conditions
- Health Condition 1: null- Patients with panic disorder with or without agoraphobia, as diagnosed by structured clinical interview for DSM-IV-TR
- Registration Number
- CTRI/2012/01/002315
- Lead Sponsor
- Ipca Laboratories Ltd Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 232
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.
Compliance
-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
Informed Consent
-Patient and LAR (if required) must have given written, personally signed and dated, informed consent to participate in the study, in accordance with the current applicable regulations, International Conference on Harmonization (ICH), Good Clinical Practice (GCP) Guidelines, before completing any study related procedures. (In case of illiterate patients, patientâ??s thumb impression and signature of LAR/impartial witness is necessary on informed consent).
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
-Patients with systolic BP 160 mm Hg and/or diastolic BP 110 mm Hg
-Patients with abnormal renal function
-Patients with abnormal liver function
-Patients with uncontrolled diabetic mellitus (random blood sugar 200mg/dL)
-Concomitant medications
-Patients who have recently begun cognitive-behavioral psychotherapy to treat panic disorder, generalized anxiety disorder, or major depression
-Patients having any concomitant medication, which may interact with action of study drugs (antidepressants, lithium, and CNS stimulants like caffeine and cocaine)
Allergy / Intolerance
-Patients with known history of hypersensitivity or allergy to any benzodiazepines or any other ingredient of the study medication
Substance abuse
-Patients with history of drug dependence or excessive alcohol intake on a habitual basis of more than two units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or measure of spirit) or have difficulty in abstaining for the duration of the study
-Patients with habitual smoking
Other clinical trials / experimental medications
-Patients who have used another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment
Others
-Pregnant or lactating women
-Women of childbearing potential not practicing contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in CGI-S scor of illness score and change in phobic fear and avoidance behaviorTimepoint: - At Baseline <br/ ><br>- At Dose Optimization Phase (after ever 2 visit) <br/ ><br>- At the end of Dose Maintenance Phase,Dose Tapering Phase and Drug free phase
- Secondary Outcome Measures
Name Time Method Change in PGI-C score, CGI-C score (for panic disorder, phobic avoidance, and anticipatory anxiety), and change in the mean duration of anticipatory anxiety, overall impairment or disability associated with work and social activities.Timepoint: -At Baseline Visit <br/ ><br>- At dose optimization phase (after every 2 visit) <br/ ><br>- At the end of dose maintenance phase, tapering phase and drug free phase <br/ ><br>