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NCT01041274 · ClinicalTrials.gov registry record · Phase 4

DECIFER: Depression and Citalopram In First Episode Recovery

A Phase 4 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 4
Development phase
95
Enrollment target

NCT01041274: Completed Phase 4 study, sponsored by NYU Langone Health.

NCT01041274 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 95 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01041274, a Phase 4 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 4
Development phase
95 participants
Enrollment target

Study Summary

This study seeks to examine the effectiveness of citalopram added to treatment with any oral or injectable second-generation antipsychotic plus standardized psychoeducation in first episode schizophrenia patients. Because depressive symptoms are common in first episode patients, we will test the hypothesis that adding the SSRI citalopram to a pre-established medication regimen will improve quality of life and decrease relapse and suicidality over the course of a 12-month trial.

Primary Outcome

The Calgary Depression Scale for Schizophrenia (CDSS) is a rater-administered assessment that measures depression in schizophrenia. The scale consists of 9 questions each rated 0 to 3. 0 corresponds with "absent" and 3 corresponds with "severe". The total score for all items is provided for each time point. The minimum score is 0 and the maximum score is 27. A higher score indicates increased depressive symptoms.

Interventions

  • DRUG Placebo
  • BEHAVIORAL Cognitive Behavioral Therapy (CBT)
  • BEHAVIORAL Psychoeducation
  • DRUG Citalopram
  • RADIATION Functional Magnetic Resonance Imaging (fMRI)

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2010-01
Est. Completion 2018-03-26
Phase Phase 4
NYU Langone Health

1,164 total trials

What the finished NCT01041274 record still lists

NCT01041274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT01041274 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01041274 about?

NCT01041274 is a clinical study titled "DECIFER: Depression and Citalopram In First Episode Recovery". This study seeks to examine the effectiveness of citalopram added to treatment with any oral or injectable second-generation antipsychotic plus standardized psychoeducation in first episode schizophrenia patients. Because depressive symptoms are common in first episode patients, we will test the hyp...

What is the current status of trial NCT01041274?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 95 participants. The study started on 2010-01. Estimated completion is 2018-03-26.

What interventions are being tested in trial NCT01041274?

The interventions under investigation include: Placebo (DRUG), Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Psychoeducation (BEHAVIORAL), Citalopram (DRUG), Functional Magnetic Resonance Imaging (fMRI) (RADIATION).

Who is sponsoring clinical trial NCT01041274?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01041274's enrollment target sits among peer trials

95 869th of 2000 higher than 1,130 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01041274, the US trial registry maintained by the National Library of Medicine. NCT01041274 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.