Phase 4
Completed N=95
DECIFER: Depression and Citalopram In First Episode Recovery
Schizophrenia · Schizophreniform Disorder
Source: ClinicalTrials.gov NCT01041274 ↗
Enrolled (actual)
95
Serious AEs
9.5%
Results posted
Nov 2018
Primary outcomePrimary: Calgary Depression Scale for Schizophrenia (CDSS) — 1.93; 2.26; 1.83; 2.58 units on a scale
◆ Published Evidence
Emerging
7citations · ~1 / year
Association of Aripiprazole With Reduced Hippocampal Atrophy During Maintenance Treatment of First-Episode Schizophrenia.
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.
Linked Publications
-
Association of Aripiprazole With Reduced Hippocampal Atrophy During Maintenance Treatment of First-Episode Schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calgary Depression Scale for Schizophrenia (CDSS) |
1.93; 2.26; 1.83; 2.58; 2.13; 1.94 | — |
| SECONDARY Scale for the Assessment of Negative Symptoms (SANS) |
19.89; 16.77; 21.37; 18.91; 16.98; 14.58 | — |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) |
39; 38.0; 33.11; 33.1; 33.3; 33.2 | — |
| SECONDARY InterSePT Scale for Suicidal Thinking (ISST) |
0.184; 0.643; 0.605; 0.462; 0.667; 0.263 | — |
| SECONDARY Heinrich Quality of Life Scale (QOL) |
71.5; 75.9; 81.0; 83.6; 86.2; 87.1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female
- Ages 16-40 years
- Schizophrenia, any subtype or Schizophreniform disorder
- Treated with any of the following second generation antipsychotics for at least 4 weeks and fewer than 16 weeks: risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, or paliperidone)
- Willing to participate in psychoeducation
- Sufficient proficiency in English to complete assessments
Exclusion Criteria
- Major depression by DSM-IV criteria
- Clinical Global Assessment of Severity of Suicidality of 3 (moderate) or greater.
- Calgary Depression Scale for Schizophrenia (CDRS) score of 7 or greater
- Serious suicide attempt within three years or ANY suicide attempt for subjects age 16-25.
- Current treatment with an MAOI or pimozide
- Active alcohol or other substance abuse or dependence within three months
- Unstable medical illness
- History of SSRI intolerance
- Pregnant or nursing
- QTc ≥ 500 msec
Data sourced from ClinicalTrials.gov (NCT01041274) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.