CTRI/2022/11/047050
Active, not recruiting
Phase 4
A Phase IV study to evaluate the safety and efficacy of Placida® [Fixed Dose Combination of Flupentixol 0.5 mg + Melitracen 10 mg] in comparison to Escitalopram 10 mg + Clonazepam 0.5 mg in patients with comorbid anxiety and depression.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: F418- Other specified anxiety disorders
- Sponsor
- Mankind Pharma Limited
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Male or female patients 18\-65 years of age.
- •2\) Patients suffering from mild to moderate comorbid anxiety and depression according to ICD\-10 criteria and prescribed either combination of escitalopram and clonazepam or Placida®.
- •3\) No life\-threatening, severe, or unstable disease/disorders or major cognitive deficits at baseline.
- •4\) Women of childbearing potential must: a) have a negative urine pregnancy test, b) not be nursing, and c) be willing to use acceptable methods of contraception throughout the study period.
- •5\) Must provide written informed consent prior to study initiation.
Exclusion Criteria
- •1\) Patients with strong suicidal tendencies.
- •2\) Patients with severe mental illnesses that could confuse assessment of depression and anxiety.
- •3\) Patients with severe anxiety and depression; with HAM\-A score \>25 and HAM\-D Score \>19\.
- •4\) Patients participating in any clinical trial currently or with in past 3 months.
- •5\) Contraindications to the study drugs according to the prescribing information.
- •6\) Treatment resistant anxiety/depression.
- •7\) Hypersensitivity to study drugs or to any of the excipients.
- •8\) Patients with organic brain syndrome, convulsion, urinary retention, hyperthyroidism, advanced hepatic or cardiovascular disease and any other serious uncontrolled concomitant disease that would contraindicate the use of any drug used in this study or that would put the patient at
- •high risk for study treatment\-related complications.
- •9\) Patients unable to comply with the protocol requirements.
Outcomes
Primary Outcomes
Not specified
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