Trial Outcomes & Findings for Prevention of Recurrence in Depression With Drugs and CT (NCT NCT00057577)
NCT ID: NCT00057577
Last Updated: 2017-05-30
Results Overview
Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
452 participants
Primary outcome timeframe
Through month 18 of treatment
Results posted on
2017-05-30
Participant Flow
Recruitment into the study started in October 2002 and the last of the 452 patients randomized completed up to three years of treatment and a subsequent three your maintenance/follow-up in July 2012
Participant milestones
| Measure |
Cognitive Therapy Plus Antidepressant Medications
Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Antidepressant Medications Alone
Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
227
|
225
|
|
Overall Study
COMPLETED
|
227
|
225
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Recurrence in Depression With Drugs and CT
Baseline characteristics by cohort
| Measure |
Cognitive Therapy Plus Antidepressant Medications
n=227 Participants
Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Antidepressant Medications Alone
n=225 Participants
Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
43.0 years
STANDARD_DEVIATION 13.4 • n=107 Participants
|
43.2 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
214 Participants
n=99 Participants
|
214 Participants
n=107 Participants
|
428 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=99 Participants
|
136 Participants
n=107 Participants
|
266 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
194 Participants
n=99 Participants
|
193 Participants
n=107 Participants
|
387 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
210 Participants
n=99 Participants
|
215 Participants
n=107 Participants
|
425 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
227 participants
n=99 Participants
|
225 participants
n=107 Participants
|
452 participants
n=206 Participants
|
|
Number of participants who met criteria for Major Depressive Disorder via SCID-MDD
|
227 participants
n=99 Participants
|
225 participants
n=107 Participants
|
452 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through month 18 of treatmentRemission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)
Outcome measures
| Measure |
Cognitive Therapy Plus Antidepressant Medications
n=227 Participants
Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Antidepressant Medications Alone
n=225 Participants
Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Prioir Meds Maintained
Patients who recovered on medication treatment were maintained on medications
|
Prior Meds Withdrawn
Patients who recovered on medication treatment were withdrawn from medications
|
|---|---|---|---|---|
|
Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)
|
187 number participants that reach remission
|
170 number participants that reach remission
|
—
|
—
|
PRIMARY outcome
Timeframe: Through 36 months of treatmentSix consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)
Outcome measures
| Measure |
Cognitive Therapy Plus Antidepressant Medications
n=227 Participants
Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Antidepressant Medications Alone
n=225 Participants
Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Prioir Meds Maintained
Patients who recovered on medication treatment were maintained on medications
|
Prior Meds Withdrawn
Patients who recovered on medication treatment were withdrawn from medications
|
|---|---|---|---|---|
|
Number of Participants in Recovery According to the LIFE and HRSD
|
165 number participants that reach recovery
|
140 number participants that reach recovery
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured up to Month 36 from recoveryRecurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)
Outcome measures
| Measure |
Cognitive Therapy Plus Antidepressant Medications
n=124 Participants
Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Antidepressant Medications Alone
n=103 Participants
Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Prioir Meds Maintained
n=111 Participants
Patients who recovered on medication treatment were maintained on medications
|
Prior Meds Withdrawn
n=114 Participants
Patients who recovered on medication treatment were withdrawn from medications
|
|---|---|---|---|---|
|
Number of Participants in Recurrence According to the LIFE and HRSD
|
78 Participants
|
85 Participants
|
79 Participants
|
103 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Throughout study, up to 54 monthsNumber Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study
Outcome measures
| Measure |
Cognitive Therapy Plus Antidepressant Medications
n=227 Participants
Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Antidepressant Medications Alone
n=225 Participants
Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Prioir Meds Maintained
Patients who recovered on medication treatment were maintained on medications
|
Prior Meds Withdrawn
Patients who recovered on medication treatment were withdrawn from medications
|
|---|---|---|---|---|
|
Serious Adverse Events
|
59 number of SAE's
|
82 number of SAE's
|
—
|
—
|
Adverse Events
Cognitive Therapy Plus Antidepressant Medications
Serious events: 59 serious events
Other events: 0 other events
Deaths: 0 deaths
Antidepressant Medications Alone
Serious events: 82 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Therapy Plus Antidepressant Medications
n=227 participants at risk
Participants will receive antidepressant medication plus cognitive therapy
Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
Antidepressant Medications Alone
n=225 participants at risk
Participants will receive maintenance of antidepressant medication alone
Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.
|
|---|---|---|
|
General disorders
Death (any cause)
|
1.3%
3/227 • Number of events 3 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
0.44%
1/225 • Number of events 1 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
|
Psychiatric disorders
Suicide Attempt
|
1.8%
4/227 • Number of events 5 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
3.6%
8/225 • Number of events 9 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
|
Psychiatric disorders
Psychiatric Hospitalizations
|
6.6%
15/227 • Number of events 19 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
12.4%
28/225 • Number of events 36 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
|
General disorders
Medical Hospitalizations
|
13.2%
30/227 • Number of events 46 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
16.4%
37/225 • Number of events 61 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.8%
4/227 • Number of events 5 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
2.2%
5/225 • Number of events 6 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
|
General disorders
Motor Vehicle Accidents (MVA)
|
0.44%
1/227 • Number of events 1 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
1.3%
3/225 • Number of events 3 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
|
General disorders
Other
|
0.88%
2/227 • Number of events 2 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
0.00%
0/225 • Acute treatment up to 18 months and continuation treatment up to 36 months following randomization with subsequent 36 month maintenance phase following recovery
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place