Trial Outcomes & Findings for Cognitive Therapy for Recurrent Depression (NCT NCT00118404)
NCT ID: NCT00118404
Last Updated: 2014-06-05
Results Overview
Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring major depressive disorder) for 2 consecutive weeks according to evaluator blinded to randomized assignment LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder. 2. = Mild symptoms 3. = Considerably less psychopathology than full criteria with no more than moderate impairment 4. = Does not meet full criteria but has major symptoms of impairment 5. = Meets criteria without extreme impairment in functioning 6. = Meets criteria with extreme impairment in functioning The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)
COMPLETED
PHASE3
523 participants
Measured at month 8
2014-06-05
Participant Flow
Adult outpatients diagnosed with recurrent major depressive disorder (MDD) using the Structured Clinical Interview for Diagnostic and Statistical Manual-IV were recruited from January 2000-July 2008. The first diagnostic evaluation was completed in March 2000.
Eligible patients (n=523) entered 12-14 weeks of acute phase cognitive therapy. Responders (no MDD \& Hamilton Rating Scale for Depression \[HRSD\] ≤12) were divided by lower \& higher risk based on the final 7 HRSD scores. Only consenting, higher risk patients (N=241) were randomized into the 3 arms below. See Jarrett \&Thase (2010) for design details.
Participant milestones
| Measure |
Continuation Phase Fluoxetine
Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.
|
Continuation Phase Cognitive Therapy
Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.
|
Continuation Phase Pill Placebo
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
69
|
|
Overall Study
COMPLETED
|
62
|
70
|
49
|
|
Overall Study
NOT COMPLETED
|
24
|
16
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Therapy for Recurrent Depression
Baseline characteristics by cohort
| Measure |
Continuation Phase Fluoxetine
n=86 Participants
Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.
|
Continuation Phase Cognitive Therapy
n=86 Participants
Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.
|
Continuation Phase Pill Placebo
n=69 Participants
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
86 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=5 Participants
|
86 participants
n=7 Participants
|
69 participants
n=5 Participants
|
241 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at month 8Population: Intention to treat analysis
Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring major depressive disorder) for 2 consecutive weeks according to evaluator blinded to randomized assignment LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder. 2. = Mild symptoms 3. = Considerably less psychopathology than full criteria with no more than moderate impairment 4. = Does not meet full criteria but has major symptoms of impairment 5. = Meets criteria without extreme impairment in functioning 6. = Meets criteria with extreme impairment in functioning The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)
Outcome measures
| Measure |
Continuation Phase Fluoxetine
n=86 Participants
Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.
|
Continuation Phase Cognitive Therapy
n=86 Participants
Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.
|
Continuation Phase Pill Placebo
n=69 Participants
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.
|
|---|---|---|---|
|
Depressive Relapse or MDD
|
18 % patients who relapsed
|
18.3 % patients who relapsed
|
32.7 % patients who relapsed
|
PRIMARY outcome
Timeframe: Measured at month 20Population: Intention to treat analysis
Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder. 2. = Mild symptoms 3. = Considerably less psychopathology than full criteria with no more than moderate impairment 4. = Does not meet full criteria but has major symptoms of impairment 5. = Meets criteria without extreme impairment in functioning 6. = Meets criteria with extreme impairment in functioning Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)
Outcome measures
| Measure |
Continuation Phase Fluoxetine
n=86 Participants
Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.
|
Continuation Phase Cognitive Therapy
n=86 Participants
Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.
|
Continuation Phase Pill Placebo
n=69 Participants
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.
|
|---|---|---|---|
|
Depressive Relapse/Recurrence or MDD
|
35.1 % patients who relapsed/recurred
|
35.0 % patients who relapsed/recurred
|
42.7 % patients who relapsed/recurred
|
PRIMARY outcome
Timeframe: Measured at month 32Population: Intention to treat analysis
Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment LIFE-PSR Scale: 1. = No residual symptoms, no current evidence of the disorder. 2. = Mild symptoms 3. = Considerably less psychopathology than full criteria with no more than moderate impairment 4. = Does not meet full criteria but has major symptoms of impairment 5. = Meets criteria without extreme impairment in functioning 6. = Meets criteria with extreme impairment in functioning Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481).
Outcome measures
| Measure |
Continuation Phase Fluoxetine
n=86 Participants
Participants received acute phase cognitive therapy and continuation phase pill placebo
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.
|
Continuation Phase Cognitive Therapy
n=86 Participants
Participants received acute phase and continuation phase cognitive therapy
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.
|
Continuation Phase Pill Placebo
n=69 Participants
Participants received acute phase cognitive therapy and continuation phase fluoxetine
Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.
Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.
|
|---|---|---|---|
|
Depressive Relapse/Recurrence or MDD
|
41.1 % patients who relapsed/recurred
|
45.2 % patients who relapsed/recurred
|
56.3 % patients who relapsed/recurred
|
Adverse Events
Continuation Phase Fluoxetine
Continuation Phase Cognitive Therapy
Continuation Phase Pill Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robin B. Jarrett, Professor of Psychiatry
The University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place