Health Condition 1: null- MAJOR DEPRESSIVE DISORDER (MDD)
Conditions
Interventions
Intervention1: IN-ASTR-001 tablet: One tablet (25 mg of active drug) to be taken in the evening for initial 14 days. On 15th day, in case of insufficient improvement, the dose will be increased to 2 t
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients (≥ 18 yrs & ≤ 65 yrs) of MDD (according to DSM-IV-TR) with HDRS-17 score 20. And at least a score of 2 in the first item of the scale at screening and at baseline. 2. The subjects should have the score of at least 4 on CGI-S scale at the enrollment visit. 3. Female patients of childbearing potential- they are willing to use a medically valid and effective contraception throughout the study period. 4. Patients are willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients recording ≥20 % reduction in HDRS-17 score at the baseline (at the time of study treatment allocation) as against the same recorded at the time of screening. 2. History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder. 3. Patients not responding to the administration of an appropriate dose of two different earlier antidepressant treatments (including fluoxetine) for at least 4 weeks each, for the current and earlier episodes. 4. History of not responding to fluoxetine monotherapy for at least 4 weeks. 5. Pregnant woman and lactating mother. 6. Substance or alcohol abuse in the last 30 days, dependence in the last 6 months. 7. Patients with a high risk of suicidal behavior, scoring 3 on item No. 3 of HDRS-17 scale. 8. Concomitant psychotropic medication, including herbal preparations. 9. Neurologic disorders (dementia, seizure and stroke) or serious or uncontrolled diseases (hypertension, angina pectoris, myocardial infarction, diabetes mellitus etc.) 10. Hepatic insufficiency (SGOT/SGPT ≥ 2.0 x ULN) or Renal insufficiency (serum creatinine ≥ 1.5 x ULN) 11. Clinically significant abnormalities on physical examination or laboratory tests 12. Ongoing use of prohibited medications (Ex: TCA antidepressants, SSRIs, sedatives-hypnotics and melatonin & its other derivatives). Washout period according to drug?s half life is allowed before screening (at least 7 days). During washout period and initial 2 weeks of the study, if required only zolpidem (max 10 mg/day) is allowed. 13. Unsuitability for enrollment otherwise as decided by investigator. 14. Patients having participated in any type of clinical study within in the last one month of the screening date.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in clinician-rated HDRS-17 Score.Timepoint: At the end of 8th wk compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical response (â?¥50% reduction in HDRS-17 score) and remission (HDRS-17 â?¤ 7) rates measured by HDRS-17 2. Clinical Global Impressions scales scores (CGI-I, CGI-S) 3. Subjective measures on sleep (from HDRS-17 insomnia component) Timepoint: At the end of 8th wk compared to baseline | — |
Countries
India
Contacts
Public ContactDr Dimple Shah
Intas Pharmaceuticals Ltd.
Outcome results
None listed