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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/05/025240

Enrollment

250

Registered

2020-05-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders

Interventions

Intervention1: FDC of Fluoxetine HCl and Alprazolam tablet: Fluoxetine HCl 20mg plus Alprazolam 0.25mg tablet once a day orally for the duration of 30 days. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and efficacy of FDC of Fluoxetine HCl 20mg + Alprazolam 0.25mg Tablets in Indian patients diagnosed with depressive disorder.Timepoint: Day (-2 to -1), Day 1, Day 8, Day 22, Day 30, Day 38	—

Secondary

Measure	Time frame
To evaluate the number of subjects whose alleviated to normal.Timepoint: Day (-2 to -1), Day 1, Day 8, Day 22, Day 30, Day 38	—

Countries

India

Contacts

Public ContactMukesh Kumar

RAHE Life Science

mukesh@rahelife.com9873038019

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026