CTRI/2011/05/001719CompletedPhase 3
An Open-Label, Randomized, Parallel Group, Prospective, Multicentre Clinical Trial for Evaluation of Efficacy and Safety of IN-ASTR-001 in Patients with Major Depressive Disorder.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 280
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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.
Investigators
Similar Trials
Completed
Phase 3
Phase III clinical trial for Evaluation of Efficacy and Safety of IN-ALRN-001 in Comparison with Tamsulosin in Patients with lower urinary tract symptoms associated with BPH.CTRI/2009/091/000742Intas Pharmaceuticals Limited200
Completed
Phase 3
Clinical Trial for Evaluation of Efficacy and Safety of Fixed Dose Combination of Minoxidil + Finasteride Solution in Comparison with Minoxidil Solution in Adult Male Patients with Androgenic AlopeciaCTRI/2009/091/000896Intas Pharmaceuticals Limited270
Suspended
Phase 3
A phase 3 clinical trial to study the efficacy and safety of drug fasudil in comparison with nimodipine in patients with non-traumatic subarachnoid hemorrhageCTRI/2010/091/000422Intas Pharmaceuticals Limited200
Active, not recruiting
Phase 4
Clinical study toevaluate the effect of flavoured oats and blended oil with antioxidants in preâ??diabetes subjectsCTRI/2015/12/006429Spectrum Clinical Research Pvt Ltd
Unknown
Phase 2
An Open-Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-Menopausal Women With Oestrogen Receptor Positive Advanced Breast CancerAdvanced Breast CancerJPRN-jRCT2080220406AstraZeneca