A clinical trial to study the effects of two drugs, fixed dose combination capsules of Paroxetine hydrochloride controlled release (CR) & Clonazepam and Paroxetine hydrochloride controlled release (CR) tablets in patients with co-morbid depression & anxiety

An open label comparative multicentric study to assess the efficacy and safety of fixed dose combination capsules of Paroxetine hydrochloride controlled release (CR) and Clonazepam in comparison to Paroxetine hydrochloride controlled release (CR) tablets in patients suffering from co-morbid depression & anxiety

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000162

Enrollment

200

Registered

2009-07-01

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: null- Co-morbid depression and anxiety Health Condition 2: F411- Generalized anxiety disorder Health Condition 3: F339- Major depressive disorder, recurrent, unspecified

Interventions

Intervention1: Fixed dose combination capsules of Paroxetine (25 mg) controlled release (CR) and Clonazepam (0.5 mg): One capsule once in a day with or without food in the morning Control Intervention

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients between 18-65 years of age 2.Patients with established diagnosis of co-morbid depression & anxiety (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition DSM-IV) with a total Hamilton Rating Scale for Depression (HAM-D) score more than and or equal to 14 and total Hamilton Rating Scale for Anxiety (HAM-A) score more than and or equal to 12 3.Informed consent of the patient or relative

Exclusion criteria

Exclusion criteria: 1.Pregnancy and/or lactation 2.Patients with a history of mania, schizophrenia, seizures, narrow angle glaucoma, pre-existing CNS depression or coma, respiratory depression, acute pulmonary insufficiency, myasthenia gravis or sleep apnoea, chronic pulmonary insufficiency and/or muscle weakness 3.Patients with suicidal tendencies 4.Patients operating hazardous machinery, including automobiles 5.Patients with renal and/or hepatic insufficiency 6.Patients taking a mono amine oxidase inhibitor (MAOI), or within 14 days of discontinuing treatment with MAOI 7.Patients who have a history of hypersensitivity to Paroxetine and/or clonazepam and/or any components of the formulations 8.Patients with any other serious concurrent illness or malignancy 9.Patients with continuing history of alcohol and/or drug abuse 10.Participation in another clinical trial in the past 3 months.

Design outcomes

Secondary

Measure	Time frame
(1)% of patients having a 50% reduction in the HAM-D and HAM-A total score at the end of the study as compared to baseline (2)% of patients having a total HAM-D and HAM-A score each of 7 at the end of the study. (3)% of patients having an assessment of 1 for ?very much improved? or 2 for ?much improved? in the global change score (CGI-I) assessment at each follow-up visit. (4)Degree of improvement in the mean CGI-S (global severity of the CGI scale) score as compared to baseline.Timepoint: 4-12 weeks	—

Measure

Time frame

(1)% of patients having a 50% reduction in the HAM-D and HAM-A total score at the end of the study as compared to baseline (2)% of patients having a total HAM-D and HAM-A score each of 7 at the end of the study. (3)% of patients having an assessment of 1 for ?very much improved? or 2 for ?much improved? in the global change score (CGI-I) assessment at each follow-up visit. (4)Degree of improvement in the mean CGI-S (global severity of the CGI scale) score as compared to baseline.Timepoint: 4-12 weeks

—

Primary

Measure	Time frame
Change in the score on the Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) at the end of treatment as compared to baselineTimepoint: 4-12 weeks	—

Countries

India

Contacts

Public ContactDr Ravindra Mittal

Cadila Healthcare Ltd.

r.mittal@zyduscadila.com07926868920

Outcome results

None listed

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