NCT01575158

Brief Summary

citalopram and clomipramine are better than placebo in preventing new episodes of depression in patients with recurrent depression

Trial Health

100
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Oct 1997

Longer than P75 for not_applicable depression

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

October 1, 1997

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

9.9 years

First QC Date

April 10, 2012

Last Update Submit

April 10, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 2 Hamilton Depression Rating Scale scores of at least 16 with one weeks interval or initiation of another antidepressant treatment

    2 years of follow-up

Secondary Outcomes (1)

  • Study termination due to adverse event or non-compliance

    2 years of follow-up

Study Arms (3)

citalopram

EXPERIMENTAL

citalopram

Drug: Citalopram

clomipramnine

ACTIVE COMPARATOR

clomipramine

Drug: Clomipramine

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

citalopram
clomipramnine
placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with recurrent depression
  • Sustained response achieved (3 consecutive monthly ratings at the HDS below 13)after a treatment requiring index episode

You may not qualify if:

  • Contraindications to study medications
  • Pregnancy
  • Substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Interventions

CitalopramClomipramine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 11, 2012

Study Start

October 1, 1997

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

April 11, 2012

Record last verified: 2012-04