NCT00446719 is a Phase 2/Phase 3 clinical trial of Rellidep in Depression, sponsored by Mount Sinai Hospital, Canada.

Who is sponsoring NCT00446719?

NCT00446719 is sponsored by Mount Sinai Hospital, Canada.

What drugs are being tested in NCT00446719?

Interventions in NCT00446719: Rellidep.

What condition does NCT00446719 study?

NCT00446719 studies Depression.

Is NCT00446719 still recruiting?

NCT00446719 is currently completed. Last updated 4 January 2011.

Last reviewed 2011-01-04 · How we verify

NCT00446719

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (BI= Biological Isolate) in Major Depressive Disorder

Completed Phase 2/Phase 3 Last updated 4 January 2011

What this trial tests

Phase 2/Phase 3 trial testing Rellidep in Depression in 23 participants. Completed in 1 December 2008.

Timeline

1 August 2007

Primary endpoint
1 December 2008

1 December 2008

Quick facts

Lead sponsor	Mount Sinai Hospital, Canada
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	1 August 2007
Primary completion	1 December 2008
Estimated completion	1 December 2008
Sites	1 location across Canada

Drugs / interventions tested

Rellidep — full drug profile →

Conditions studied

Depression — all drugs for Depression →

Sponsor

Mount Sinai Hospital, Canada

Who can join

Adults 18 to 64, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks
Time frame: 8 weeks

Sponsor's own description

The investigators hypothesize that Rellidep will be effective in improving the symptoms of major depression. The available evidence strongly suggests that Rellidep contains a mood altering ingredient or ingredients. This open-label, non-randomized study sets out to validate its potential antidepressant activity.The study will include secondary aims of evaluating the effect of Rellidep on reducing symptoms of anxiety, a common symptom associated symptom of depression and improving quality of life. About twenty-five patients with major depressive disorder will be assigned to open-label Rellidep (2000 mg/day) for a period of 8 weeks. All patients will be assessed by various measures of global improvement, depression, quality of life, sexual experience, anxiety and measures of side effects as well as standard laboratory tests.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Depression

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Other Mount Sinai Hospital, Canada trials

Trials by the same sponsor.

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NCT06546254 — 1% Lidocaine Paracervical Block for Endometrial Biopsy · NA · completed
NCT06733701 — The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00446719 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mount Sinai Hospital, Canada
Last refreshed: 4 January 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00446719.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing