A multi-centric, open-label, non-comparative Phase-IV clinical trial (active post marketing surveillance study) to evaluate safety and efficacy of FDC of Fluoxetine HCl 20mg plus Alprazolam 0.25mg tablet in patients diagnosed with depressive disorder

Salute Bestochem Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

发起方

Salute Bestochem Pvt Ltd