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Sustaining Remission of Psychotic Depression (STOP-PD)

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ClinicalTrials.gov Identifier: NCT01427608
Recruitment Status : Completed
First Posted : September 1, 2011
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
University of Toronto
University of Massachusetts, Worcester
University of Pittsburgh
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psychotic Depression
Interventions Drug: Sertraline + Olanzapine
Drug: Sertraline + Placebo
Enrollment 269
Recruitment Details  
Pre-assignment Details 269 participants were enrolled in the open-label phase. However, only 126 participants were eligible and consented to participate in the RCT phase. Reasons for not being eligible for the RCT phase included failure to achive remission criteria, discontinuation of treatment prior to the RCT, or decision by the participant not to consent to the RCT.
Arm/Group Title Sertraline + Olanzapine Sertraline + Placebo
Hide Arm/Group Description Randomized to continue with sertraline and olanzapine under double-blind conditions Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
Period Title: Overall Study
Started 64 62
Completed 43 24
Not Completed 21 38
Reason Not Completed
Death             1             0
Withdrawal by Subject             7             3
Relapsed-all cause             13             34
Events not attributed to study meds             0             1
Arm/Group Title Sertraline + Olanzapine Sertraline + Placebo Total
Hide Arm/Group Description Randomized to continue with sertraline and olanzapine under double-blind conditions Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions Total of all reporting groups
Overall Number of Baseline Participants 64 62 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 62 participants 126 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
  70.3%
42
  67.7%
87
  69.0%
>=65 years
19
  29.7%
20
  32.3%
39
  31.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 62 participants 126 participants
55.0  (15.1) 55.7  (14.9) 55.3  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 62 participants 126 participants
Female
37
  57.8%
41
  66.1%
78
  61.9%
Male
27
  42.2%
21
  33.9%
48
  38.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 62 participants 126 participants
Hispanic or Latino
6
   9.4%
9
  14.5%
15
  11.9%
Not Hispanic or Latino
58
  90.6%
53
  85.5%
111
  88.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 62 participants 126 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   6.3%
3
   4.8%
7
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   9.4%
9
  14.5%
15
  11.9%
White
54
  84.4%
49
  79.0%
103
  81.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.6%
1
   0.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 62 participants 126 participants
Canada 24 23 47
United States 40 39 79
Hamilton Depression Rating Scale 17-Item Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 64 participants 62 participants 126 participants
5.3  (3.6) 5.6  (3.6) 5.5  (3.6)
[1]
Measure Description: Hamilton Depression Rating Scale (HDRS) 17-item; The total score can range from 0-52. A higher score indicates worsening severity of depressive symptoms.
Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 64 participants 62 participants 126 participants
178.6  (39.4) 182.5  (39.8) 180.5  (39.5)
Total Cholesterol level  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 64 participants 62 participants 126 participants
209.0  (51.3) 220.4  (46.8) 214.7  (49.3)
Triglycerides  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 64 participants 62 participants 126 participants
134
(90 to 186)
121
(95 to 169)
127
(95 to 180)
1.Primary Outcome
Title Number of Subjects at Risk of Relapse During the Randomized Phase.
Hide Description

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.

Time Frame From entry into randomized phase (baseline) and 36 weeks or earlier relapse
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline + Olanzapine Sertraline + Placebo
Hide Arm/Group Description:
Randomized to continue with sertraline and olanzapine under double-blind conditions
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
Overall Number of Participants Analyzed 64 62
Measure Type: Count of Participants
Unit of Measure: Participants
13
  20.3%
34
  54.8%
2.Secondary Outcome
Title Changes in Metabolic Measures: Weight
Hide Description Change in weight from entry into randomized phase (baseline) and 36 weeks.
Time Frame From entry into randomized phase (baseline) and 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline + Olanzapine Sertraline + Placebo
Hide Arm/Group Description:
Randomized to continue with sertraline and olanzapine under double-blind conditions
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
Overall Number of Participants Analyzed 64 62
Mean (95% Confidence Interval)
Unit of Measure: pounds
5.70
(3.30 to 8.11)
-3.11
(-5.41 to -0.81)
3.Secondary Outcome
Title Changes in Metabolic Measure: Cholesterol
Hide Description Change in cholesterol from entry into randomized phase (baseline) and 36 weeks.
Time Frame From entry into randomized phase (baseline) and 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline + Olanzapine Sertraline + Placebo
Hide Arm/Group Description:

Randomized to continue with sertraline and olanzapine under double-blind conditions.

Sertraline + Olanzapine: Olanzapine 15mg/day. Adjustment of dose to 5mg/day to a maximum of 20mg/day will be permitted if necessitated by significant side-effects or clinical worsening

Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions.

Sertraline + Placebo: Taper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study.

Overall Number of Participants Analyzed 64 62
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-0.46
(-14.90 to 5.57)
-22.28
(-32.71 to -11.86)
4.Secondary Outcome
Title Changes in Metabolic Measures: Triglycerides
Hide Description Change in triglycerides from entry into randomized phase (baseline) and 36 weeks.
Time Frame From entry into randomized phase (baseline) and 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sertraline + Olanzapine Sertraline + Placebo
Hide Arm/Group Description:
Randomized to continue with sertraline and olanzapine under double-blind conditions
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
Overall Number of Participants Analyzed 64 62
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-3.85
(-31.68 to 23.99)
-18.18
(-30.05 to -6.31)
Time Frame 36 Weeks of RCT Phase
Adverse Event Reporting Description Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated <3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of >7% from pre-morbid weight, b. weight loss of >7% from pre-morbid weight in the RCT phase.
 
Arm/Group Title Sertraline + Olanzapine Sertraline + Placebo
Hide Arm/Group Description Randomized to continue with sertraline and olanzapine under double-blind conditions Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
All-Cause Mortality
Sertraline + Olanzapine Sertraline + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/64 (1.56%)      0/62 (0.00%)    
Hide Serious Adverse Events
Sertraline + Olanzapine Sertraline + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/64 (17.19%)      12/62 (19.35%)    
Surgical and medical procedures     
Hospitalisation  1  11/64 (17.19%)  11 12/62 (19.35%)  12
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sertraline + Olanzapine Sertraline + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/64 (45.31%)      23/62 (37.10%)    
Gastrointestinal disorders     
Constipation  1  0/64 (0.00%)  0 1/62 (1.61%)  1
Diarrhoea  1  4/64 (6.25%)  4 1/62 (1.61%)  2
Dry mouth  1  0/64 (0.00%)  0 1/62 (1.61%)  1
Nausea  1  2/64 (3.13%)  2 4/62 (6.45%)  5
General disorders     
Fatigue  1  2/64 (3.13%)  2 1/62 (1.61%)  1
Infections and infestations     
Urinary tract infection  1  1/64 (1.56%)  1 0/62 (0.00%)  0
Investigations     
Weight decreased  1  3/64 (4.69%)  5 3/62 (4.84%)  3
Weight increased  1  9/64 (14.06%)  11 3/62 (4.84%)  3
Musculoskeletal and connective tissue disorders     
Musculoskeletal stiffness  1  1/64 (1.56%)  1 0/62 (0.00%)  0
Nervous system disorders     
Dizziness postural  1  5/64 (7.81%)  5 2/62 (3.23%)  2
Headache  1  3/64 (4.69%)  3 1/62 (1.61%)  1
Hypersomnia  1  2/64 (3.13%)  2 3/62 (4.84%)  3
Somnolence  1  4/64 (6.25%)  5 2/62 (3.23%)  2
Psychiatric disorders     
Abnormal dreams  1  1/64 (1.56%)  2 1/62 (1.61%)  1
Depression  1  1/64 (1.56%)  1 0/62 (0.00%)  0
Indifference  1  1/64 (1.56%)  1 0/62 (0.00%)  0
Insomnia  1  2/64 (3.13%)  2 4/62 (6.45%)  4
Libido decreased  1  4/64 (6.25%)  4 0/62 (0.00%)  0
Tension  1  3/64 (4.69%)  3 0/62 (0.00%)  0
Renal and urinary disorders     
Polyuria  1  1/64 (1.56%)  1 0/62 (0.00%)  0
Pollakiuria  1  1/64 (1.56%)  1 0/62 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  1/64 (1.56%)  1 2/62 (3.23%)  2
Pruritus  1  0/64 (0.00%)  0 1/62 (1.61%)  1
Rash  1  2/64 (3.13%)  2 0/62 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. George S. Alexopoulos
Organization: Weill Cornell Medicine
Phone: (914) 997-5767
EMail: gsalexop@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01427608    
Other Study ID Numbers: STOP-PD-II
First Submitted: August 30, 2011
First Posted: September 1, 2011
Results First Submitted: December 17, 2018
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019