A non-comparative Phase-IV clinical trial to evaluate safety and efficacy of FDC of Fluoxetine HCl 20mg plus Alprazolam 0.25mg tablet in patients diagnosed with depressive disorder
- Conditions
- Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
- Registration Number
- CTRI/2020/05/025240
- Lead Sponsor
- Salute Bestochem Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures.
2. Diagnosis of generalized anxiety disorder as assessed by Structured Clinical Interview for DSM-IV (SCID-IV).
3. Depressive symptom scores measured by Hamilton Depression Rating Scale at screening and base line assessments from greater than equal to 8 and less than equal to sixteen.
4. Patient willing to comply with the protocol requirements.
1. Subjects who are not able to or not willing to sign an IRB/IEC approved consent form.
2. Presence of any major physical or neurological illness (Eg. Head trauma, Epilepsy, Seizures, Stroke, Cerebral Tumor, Multiple Sclerosis, Cerebrovascular disease, Narrow-angle glaucoma, drug hypersensitivity, etc.)
3. Drug abuse in past three months.
4. Contraindications to Magnetic Resonance Imaging (Eg. Pacemaker implantation, claustrophobia, etc.)
5. Diagnosis of any axis I disorder other than generalized anxiety disorder or presence of symptoms requiring hospitalization.
6. Acute heart disease.
7. Major depressive episode during past 12 months.
8. Depressive symptom score measured by Hamilton depression rating scale: greater than equal to 17.
9. Women who are pregnant, breastfeeding, or planning pregnancy.
10. Contraindications to drugs used in the study (Eg. Allergy, Intolerance, etc)
11. Unstable medical illness or severe abnormality in laboratory test at screening assessment.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method