Health Condition 1: F411- Generalized anxiety disorder
Conditions
Interventions
Intervention1: Capsule Etifoxine 50 mg: Patient will receive one Etifoxine 50 mg capsule orally, in morning along with matching placebo of Alprazolam 0.5 mg tablet
one Etifoxine 50 mg capsule orally, in afternoon along with matching placebo of Alprazolam 0.5 mg tablet
and one Etifoxine 50 mg capsule orally, in evening along with matching placebo of Alprazolam 0.5 mg tablet.
(Each dosing interval should approximately 8 hours apart) It can be taken with or without fo
one Alprazolam 0.5 mg tablet orally, in afternoon along with matching placebo of Etifoxine 50 mg Capsule
and one Alprazolam 0.5 mg tablet orally, in evening along with matching placebo of Etifoxine 50 mg Capsule. It can be taken with or without food for 28 days
Sponsors
Sun Pharma Laboratories Limited (SPLL)
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients of either gender, aged between 18 to 65 years (both inclusive), and willing to provide written informed consent 2) Patient should have a clinical diagnosis of generalized anxiety disorder as per Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) 3) Patients with Hamilton Anxiety Rating Scale (HAM-A) total score =20 at Screening and Randomization 4) Patient should have a score of =10 on Somatic Sub-scale items (Items 7 to 13) and Psychic Sub-scale items (Items 1 to 6 & 14) of HAM-A Scale at Screening and Randomization 5) Patients with Mini Mental State Examination (MMSE) Score = 24 at Screening and Randomization 6) Adult caregiver is willing and able to accompany the patient to all visits 7) Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence) [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age] 8) Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period). No sperm donation is allowed during the study period
Exclusion criteria
Exclusion criteria: 1) Patients with DSM-5 diagnosis of anxiety disorders other than generalized anxiety disorder 2) Patients with Hamilton Depression Rating Scale (HAM-D; 17 items) total score =17, and/or a score of =3 on Suicide item of HAM-D 17-items scale at Screening and randomization 3) Patients with current diagnoses (within the 6 months) of obsessive compulsive disorder, posttraumatic stress disorder, anorexia, and bulimia 4) Patients with past or current diagnoses of schizophrenia, psychotic disorder, delirium, dementia, bipolar or schizoaffective disorder, cyclothymic disorder, dissociative disorders, antisocial or borderline personality disorder 5) Patients taking the following medications: - Fluoxetine in the last 28 days prior to randomization; - Anxiolytics, antipsychotics/neuroleptics, Monoamine oxidase (MAO) inhibitors, mood stabilizers, anticonvulsants or other antidepressants [(Selective serotonin reuptake inhibitor (SSRIs), Serotonin–norepinephrine reuptake inhibitor (SNRIs), Tricyclic antidepressants (TCAs)] in the last 14 days prior to randomization [Note: Patients on long acting injectable antipsychotics are allowed if these drugs have been stopped at least 2 full cycle prior to randomization (length of 1 cycle is based on the prescribing label)] - Central nervous system stimulants and hypnotics (except for selective gamma-Aminobutyric acid (GABA) -A receptor alpha-1 subunit agonists such as zolpidem), beta-blockers, clonidine, sumatriptan, antihistamines that cause sedation, phyto-therapeutics with an anxiolytic action in the last 7 days prior to randomization 6) Patients taking any Cytochrome P450 3A4 (CYP 3A4) inhibitor(s) or strong CYP 3A4 inducer(s) that requires washout period > 7 days. (Note: Patients on CYP3A4 inhibitor(s) or strong CYP 3A4 inducer(s) with 5 half-life (elimination) (t1/2e) = 7 days will require a 7-days drug-free washout during run-in period. Patients who were earlier on CYP3A4 inhibitor(s) or strong CYP 3A4 inducer(s) with 5 t1/2e > 7 days, are allowed if the drug(s) has been stopped for more than 5 t1/2e of the drug prior to Randomization for a reason not related to study-specific requirement) 7) Patients who have recently begun cognitive-behavioral psychotherapy to treat generalized anxiety disorder, or major depression 8) Patients who are known case of uncontrolled narrow-angle glaucoma 9) Patients with uncontrolled diabetic mellitus (random blood sugar 200 mg/dL), states of shock, and myasthenia 10) Patients with severely impaired liver function [Aspartate transaminase (AST) or Alanine transaminase (ALT) >3 times upper limit of normal (ULN) and/or renal function (eGFR 11) Patients with history of severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Steven Johnson Syndrome (SJS), acute generalized exanthematous pustulosis (AGEP) or erythema multiforme (EM) 12) Patients who are professional drivers or machinery workers, patients involved in works that need constant alertness 13) History of any cancer within 5 years of screening 14) Patient who is at imminent risk of suicide or homicide, or had a suicide attempt within 01 year prior to screening 15) Patients with diagnosis of convulsive disorders within the last 6 months (for example: epilepsy, cranial trauma) and/or current use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) total score at Day 28Timepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1. Change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) total score at Days 7 & 14 2. Change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) psychic sub-score at Days 7, 14 & 28 3. Change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) somatic sub-score at Days 7, 14 & 28 4. Change from baseline in Clinical Global Impression-Severity Scale (CGI-S) score at Days 7, 14 & 28 5. Percentage of patients with Clinical Global Impression-Improvement Scale (CGI-I) response at Days 7, 14 & 28 6. Percentage of patients with Patient Global Impression-Improvement Scale (PGI-I) response at Days 7, 14 & 28 Safety: 1. Change from baseline in Cognitive Assessment Score at Day 28 2. Treatment emergent adverse event (TEAE) [Time Frame: Throughout the study period] Note: Cognitive assessment will be assessed by Mini Mental State Examination using MMSE-2 Standard Version FormTimepoint: Efficacy 1. Days 7 & 14 2. Days 7, 14 & 28 3. Days 7, 14 & 28 4. Days 7, 14 & 28 5. Days 7, 14 & 28 6. Days 7, 14 & 28 Safety: 1. Day 28 2. Treatment emergent adverse event (TEAE) [Time Frame: Throughout the study period] Note: Cognitive assessment will be assessed by Mini Mental State Examination using MMSE-2 Standard Version Form | — |
Countries
India
Contacts
Public ContactChaitali Bornare
Sun Pharma Laboratories Limited
Outcome results
None listed