NCT02179268

Brief Summary

The aim of this five arm randomized trial was thus to compare selective serotonin reuptake inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the primary endpoint being bone mineral density, and secondary endpoints being bone turnover markers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

2.1 years

First QC Date

June 19, 2014

Last Update Submit

June 28, 2014

Conditions

Bone Mineral Density Quantitative Trait Locus 7

Keywords

Antidepressantsbone mineral densitybone turnover markers

Outcome Measures

Primary Outcomes (1)

  • bone mineral density (BMD)

    Change from Baseline in bone mineral density at one year

Study Arms (4)

sertraline & control

ACTIVE COMPARATOR

sertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

Drug: sertralineDrug: citalopramDrug: venlafaxineDrug: reboxetineBehavioral: control

citalopram & Control

ACTIVE COMPARATOR

citalopram 20-40mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

Drug: sertralineDrug: citalopramDrug: venlafaxineDrug: reboxetineBehavioral: control

venlafaxine & control

ACTIVE COMPARATOR

venlafaxine 75-100mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

Drug: sertralineDrug: citalopramDrug: venlafaxineDrug: reboxetineBehavioral: control

reboxetine & control

ACTIVE COMPARATOR

reboxetine 4-8mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

Drug: sertralineDrug: citalopramDrug: venlafaxineDrug: reboxetineBehavioral: control

Interventions

sertralineDRUG

50mg, 50-150mg/d,qd for one year

Also known as: Zoloff
citalopram & Controlreboxetine & controlsertraline & controlvenlafaxine & control
citalopramDRUG

20mg, 20-40mg/d,qd,for one year

Also known as: Cipramil
citalopram & Controlreboxetine & controlsertraline & controlvenlafaxine & control
venlafaxineDRUG

venlafaxine,25mg, 75-100mg/d, bid, for one year

Also known as: Effexor
citalopram & Controlreboxetine & controlsertraline & controlvenlafaxine & control
reboxetineDRUG

reboxetine,4mg, 4-8mg/d,qd for one year

Also known as: Edronax
citalopram & Controlreboxetine & controlsertraline & controlvenlafaxine & control
controlBEHAVIORAL

50min, every week for three months, every month, for nine months

Also known as: cognitive behavioral therapy
citalopram & Controlreboxetine & controlsertraline & controlvenlafaxine & control

Eligibility Criteria

Age20 Years - 48 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants needed to have a primary diagnosis of depression with Zung Self Rated Depression Scale (SDS) \> 53, and Hamilton Depression Scale (HAMD) ≥20.

You may not qualify if:

  • The patients with hyperparathyroidism, myeloma or other disorders known to affect bone metabolism
  • Use of estrogen
  • Calcitonin drugs
  • Previous antidepressant or other psychiatric drug use or prior treatment history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

SertralineCitalopramDexetimideVenlafaxine HydrochlorideReboxetineCognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsPropylaminesNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingCyclohexanolsHexanolsFatty AlcoholsAlcoholsPhenethylaminesEthylaminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicLipidsMorpholinesOxazinesBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • yiming wang, Ph.D

    World Health Organization

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Psychiatry, the Affiliated Hospital

Study Record Dates

First Submitted

June 19, 2014

First Posted

July 1, 2014

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 1, 2014

Record last verified: 2014-06