Trial · NCT01427608

Sustaining Remission of Psychotic Depression

NCT01427608, Phase 4, Completed, Weill Medical College of Cornell University; results first posted 2019-03-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sustaining Remission of Psychotic Depression. Trials, record NCT01427608. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01427608

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sustaining Remission of Psychotic Depression
NCT number: NCT01427608
Status: Completed
Phases: Phase 4
Enrollment: 269 participants, actual
Lead sponsor: Weill Medical College of Cornell University
Conditions: Psychotic Depression
Interventions: Sertraline + Olanzapine, Sertraline + Placebo
First posted: 2011-09-01
Last updated: 2019-03-05
Results first posted: 2019-03-05

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects at Risk of Relapse During the Randomized Phase.	From entry into randomized phase (baseline) and 36 weeks or earlier relapse	Relapse criteria include at least one of the following: 1)Structured Clinical Interview for Diagnostic Statistical Manual #4 Trade Revision (DSM-IV-TR) Axis 1 Disorders (SCID) symptoms of major depression maintained over two weeks 2)17-item Hamilton Depression Rating Scale score of \>17 maintained for more than one week + a mean increase of 5 points from entry into randomized phase 3)Re-emergence of psychosis for more than one week, with a SADS (Schedule for Affective Disorders and Schizophrenia) score of \>2 on delusion or hallucination severity items 4)Significant clinical worsening defined as either emergence of high-risk of suicide, and/or development of mania for greater than one week, and/or psychiatric hospitalization.
Secondary	Changes in Metabolic Measures: Weight	From entry into randomized phase (baseline) and 36 weeks	Change in weight from entry into randomized phase (baseline) and 36 weeks.
Secondary	Changes in Metabolic Measure: Cholesterol	From entry into randomized phase (baseline) and 36 weeks	Change in cholesterol from entry into randomized phase (baseline) and 36 weeks.
Secondary	Changes in Metabolic Measures: Triglycerides	From entry into randomized phase (baseline) and 36 weeks	Change in triglycerides from entry into randomized phase (baseline) and 36 weeks.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Subjects at Risk of Relapse During the Randomized Phase.	From entry into randomized phase (baseline) and 36 weeks or earlier relapse	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes in Metabolic Measures: Weight	From entry into randomized phase (baseline) and 36 weeks	pounds	MEAN
SECONDARY	Changes in Metabolic Measure: Cholesterol	From entry into randomized phase (baseline) and 36 weeks	mg/dL	MEAN
SECONDARY	Changes in Metabolic Measures: Triglycerides	From entry into randomized phase (baseline) and 36 weeks	mg/dL	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Subjects at Risk of Relapse During the Randomized Phase.	Sertraline + Olanzapine	13		Participants
Number of Subjects at Risk of Relapse During the Randomized Phase.	Sertraline + Placebo	34		Participants
Changes in Metabolic Measures: Weight	Sertraline + Olanzapine	5.70	95% Confidence Interval 3.30 to 8.11	pounds
Changes in Metabolic Measures: Weight	Sertraline + Placebo	-3.11	95% Confidence Interval -5.41 to -0.81	pounds
Changes in Metabolic Measure: Cholesterol	Sertraline + Olanzapine	-0.46	95% Confidence Interval -14.90 to 5.57	mg/dL
Changes in Metabolic Measure: Cholesterol	Sertraline + Placebo	-22.28	95% Confidence Interval -32.71 to -11.86	mg/dL
Changes in Metabolic Measures: Triglycerides	Sertraline + Olanzapine	-3.85	95% Confidence Interval -31.68 to 23.99	mg/dL
Changes in Metabolic Measures: Triglycerides	Sertraline + Placebo	-18.18	95% Confidence Interval -30.05 to -6.31	mg/dL

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sertraline + Olanzapine	64
Overall Study	STARTED	Sertraline + Placebo	62
Overall Study	COMPLETED	Sertraline + Olanzapine	43
Overall Study	COMPLETED	Sertraline + Placebo	24
Overall Study	NOT COMPLETED	Sertraline + Olanzapine	21
Overall Study	NOT COMPLETED	Sertraline + Placebo	38

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abnormal dreams	Psychiatric disorders	Sertraline + Olanzapine	1	64	2
other	Abnormal dreams	Psychiatric disorders	Sertraline + Placebo	1	62	1
other	Constipation	Gastrointestinal disorders	Sertraline + Olanzapine	0	64	0
other	Constipation	Gastrointestinal disorders	Sertraline + Placebo	1	62	1
other	Depression	Psychiatric disorders	Sertraline + Olanzapine	1	64	1
other	Depression	Psychiatric disorders	Sertraline + Placebo	0	62	0
other	Diarrhoea	Gastrointestinal disorders	Sertraline + Olanzapine	4	64	4
other	Diarrhoea	Gastrointestinal disorders	Sertraline + Placebo	1	62	2
other	Dizziness postural	Nervous system disorders	Sertraline + Olanzapine	5	64	5
other	Dizziness postural	Nervous system disorders	Sertraline + Placebo	2	62	2

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sertraline + Olanzapine	1	64
Total, all-cause mortality	Sertraline + Placebo	0	62
Total, other adverse events	Sertraline + Olanzapine	29	64
Total, other adverse events	Sertraline + Placebo	23	62
Total, serious adverse events	Sertraline + Olanzapine	11	64
Total, serious adverse events	Sertraline + Placebo	12	62

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23351522	DERIVED	PubMed
31207561	DERIVED	PubMed
31429896	DERIVED	PubMed
32101271	DERIVED	PubMed
36535116	DERIVED	PubMed
37149056	DERIVED	PubMed
37258617	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sertraline + Olanzapine vs Sertraline + Placebo: deaths from any cause	Trial comparisons
Sertraline + Olanzapine vs Sertraline + Placebo: Number of Subjects at Risk of Relapse During the Randomized Phase.	Trial comparisons
Sertraline + Olanzapine vs Sertraline + Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01427608

GET https://conductscience.org/api/trials/v1/NCT01427608/events?page=2

API reference For AI assistants