Health Condition 1: F418- Other specified anxiety disorders
Conditions
Interventions
Intervention1: FDC of Flupentixol 0.5 mg (as 0.584 mg flupentixol dihydrochloride) plus Melitracen 10 mg (as 11.25 mg melitracen hydrochloride): 2 tablets daily: morning and noon in the 1st week
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Sponsors
Mankind Pharma Limited
Eligibility
Inclusion 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
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. 10) Patients with continuing history of alcohol and/or drug abuse. 11) Patients taking a mono-amine oxidase inhibitor (MAOI), or within 14 days of discontinuing treatment with MAOI. 12) Patients on other maintenance medications for anxiety/depression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Incidence and severity of adverse events (AEs) 2) Incidence of serious adverse events (SAEs)Timepoint: Upto week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change from baseline in HAM-A scores at Week 4, 8 and 16 2) Change from baseline in HAM-D scores at Week 4, 8 and 16. 3) Score-reducing rate for HAM-A and HAM-D scores (defined as percent reduction in HAM-A and HAM-D scores) from Baseline to End of Treatments 4) Treatment Compliance 5) Extrapyramidal Symptom Rating Scale (ESRS) questionnaire for Placida® , a fixed-dose combination of Flupentixol and Melitracen (0.5 mg and 10 mg) in comparison to Escitalopram and Clonazepam (10 mg and 0.5 mg) at week 16, and end of study.Timepoint: Upto week 24 | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Service
Outcome results
None listed