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D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions

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ClinicalTrials.gov Identifier: NCT01981759
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : July 9, 2018
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizoaffective Disorder
Delusional Disorder
Interventions Drug: D-Cycloserine
Other: Placebo
Behavioral: Cognitive Behavioral Therapy
Enrollment 58
Recruitment Details  
Pre-assignment Details As the screening period lasts up to four weeks before the baseline visit and participants are not randomized until week 3, 59 participants were either screen failures or dropped out before randomization to treatment group.
Arm/Group Title Placebo D-Cycloserine
Hide Arm/Group Description

Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Period Title: Overall Study
Started [1] 28 30
Baseline (Week 1) 28 30
Randomization (Week 3) 28 30
Completed Week 12 22 22
Completed [2] 21 19
Not Completed 7 11
[1]
Screened
[2]
Week 36/All Follow-Up
Arm/Group Title Placebo D-Cycloserine Total
Hide Arm/Group Description

Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Total of all reporting groups
Overall Number of Baseline Participants 28 30 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 30 participants 58 participants
45.55  (11.97) 44.60  (13.26) 44.82  (12.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Female
12
  42.9%
11
  36.7%
23
  39.7%
Male
16
  57.1%
19
  63.3%
35
  60.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Hispanic or Latino
3
  10.7%
2
   6.7%
5
   8.6%
Not Hispanic or Latino
25
  89.3%
28
  93.3%
53
  91.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  48.0%
9
  36.0%
21
  42.0%
White
10
  40.0%
14
  56.0%
24
  48.0%
More than one race
3
  12.0%
1
   4.0%
4
   8.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Data is reported for all participants who reported "race". Not all participants provided responses for this item.
1.Primary Outcome
Title Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D)
Hide Description The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 12. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
For week 12 values, only those who completed the week 12 assessments are included in the analysis.
Arm/Group Title Placebo D-Cycloserine
Hide Arm/Group Description:

Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Overall Number of Participants Analyzed 28 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline PSYRATS Delusion Subscale Total Number Analyzed 28 participants 30 participants
14.26  (5.30) 11.83  (5.58)
Week 12 PSYRATS Delusion Subscale Total Number Analyzed 22 participants 22 participants
12.18  (3.79) 11.91  (5.26)
2.Secondary Outcome
Title Change in Logical Memory Test-WMS-III
Hide Description

The Logical Memory Test of the Wechsler Memory Scale is a measure of verbal declarative memory. We are using it to evaluate memory consolidation by analyzing the number of thematic elements recalled after a delay of 7 days. Participants are read two different stories—one at Screening visit #2 and one at Baseline. They are asked to recall specific items and narrative themes after delays of 30 minutes and 7 days. Scores range from 0-7, 7 indicating perfect thematic recall, and 0 indicating no thematic elements were remembered and worse thematic recall.

We hypothesize that improved memory consolidation tested 7 days after the first dose of D-cycloserine will predict improvement of delusional scores measured by the PSYRATS-D.

The reported outcome (change in Logical Memory Test score) was calculated by subtracting the screening visit 2 score from the baseline score for each participant.

Time Frame Screening Visit 2 to Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Reported summary statistics are for participants randomized at three weeks. One randomized participant is excluded from these results as they did not complete the Logical Memory Test at the baseline visit.
Arm/Group Title Placebo D-Cycloserine
Hide Arm/Group Description:

Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: Change in a score
-0.96  (1.32) -1.03  (1.30)
3.Secondary Outcome
Title Change in Alternate Beliefs Exercise (ABE)
Hide Description

The Alternate Belief Exercise is a measurement of cognitive flexibility. The scores range from 0-21, and a higher score indicates an increased number of alternative beliefs reported.

This outcome measurement reports the change in number of alternate beliefs generated from weeks 3 to 4 as a predictor of improvement of the PSYRATS Delusions Subscale total score at 12 weeks. Thus a higher score in this outcome measurement indicates a greater number of alternative beliefs reported at week 4 as compared to week 3. This implies greater cognitive flexibility at week 4 as compared to week 3 directly after drug administration.

Time Frame Week 3 to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants were randomized and took medication (placebo or DCS) at week 3, but were lost to follow up between week 3 and week 4. One participant was randomized at week 3 but did not take medication or complete the ABE exercise at week 3. These three participants are not included in the reported data.
Arm/Group Title Placebo D-Cycloserine
Hide Arm/Group Description:

Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Participants will receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Overall Number of Participants Analyzed 26 29
Mean (Standard Deviation)
Unit of Measure: Change in a score
1.15  (2.80) 0.59  (1.84)
Time Frame Entire study duration, from Randomization through the final follow-up at Week 36.
Adverse Event Reporting Description Adverse Event reporting is based on self-report on the Systematic Assessment of Treatment Emergent Effects (SAFTEE).
 
Arm/Group Title Placebo D-Cycloserine
Hide Arm/Group Description

Participants receive a weekly dose of placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from week 1-12 (12 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

Participants will receive a weekly dose of 50 mg placebo by mouth one hour before Cognitive Behavioral Therapy (CBT) sessions from weeks 1-2 (2 visits), then a weekly 50 mg dose of D-Cycloserine by mouth one hour before CBT sessions from weeks 3-12 (10 visits).

Cognitive Behavioral Therapy: Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.

All-Cause Mortality
Placebo D-Cycloserine
Affected / at Risk (%) Affected / at Risk (%)
Total   24/28 (85.71%)      24/30 (80.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo D-Cycloserine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      3/30 (10.00%)    
Infections and infestations     
Medical Hospitalization   0/28 (0.00%)  0 2/30 (6.67%)  2
Psychiatric disorders     
Psychiatric Hospitalization   0/28 (0.00%)  0 1/30 (3.33%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo D-Cycloserine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/28 (85.71%)      24/30 (80.00%)    
Cardiac disorders     
Bradycardia   1/28 (3.57%)  1 0/30 (0.00%)  0
Hypertension   1/28 (3.57%)  1 0/30 (0.00%)  0
Ear and labyrinth disorders     
Ear Feels Clogged   0/28 (0.00%)  0 1/30 (3.33%)  1
Endocrine disorders     
Blood Sugar Increased   0/28 (0.00%)  0 1/30 (3.33%)  1
Eye disorders     
Blurred Vision   3/28 (10.71%)  3 1/30 (3.33%)  1
Eye Hemorrhage   0/28 (0.00%)  0 1/30 (3.33%)  1
Gastrointestinal disorders     
Constipation   0/28 (0.00%)  0 2/30 (6.67%)  2
Diarrhea   1/28 (3.57%)  1 0/30 (0.00%)  0
Nausea and Vomiting   2/28 (7.14%)  2 2/30 (6.67%)  2
Stomach Pain   0/28 (0.00%)  0 1/30 (3.33%)  1
General disorders     
Dry Mouth   2/28 (7.14%)  2 3/30 (10.00%)  3
Facial Swelling   1/28 (3.57%)  1 0/30 (0.00%)  0
Hair Loss   0/28 (0.00%)  0 1/30 (3.33%)  1
Hair Thinning   1/28 (3.57%)  2 1/30 (3.33%)  1
Hot Flashes   1/28 (3.57%)  1 1/30 (3.33%)  1
Hepatobiliary disorders     
Frequency of Urination   0/28 (0.00%)  0 2/30 (6.67%)  2
Infections and infestations     
Common Cold   4/28 (14.29%)  5 1/30 (3.33%)  2
Nasal Congestion   1/28 (3.57%)  1 4/30 (13.33%)  4
Flu-like Symptoms   0/28 (0.00%)  0 1/30 (3.33%)  1
Gingival Bleeding   0/28 (0.00%)  0 1/30 (3.33%)  1
Infection   1/28 (3.57%)  1 0/30 (0.00%)  0
Upper Respiratory Infection   0/28 (0.00%)  0 1/30 (3.33%)  1
Pneumonia and Dehydration   1/28 (3.57%)  1 0/30 (0.00%)  0
Metabolism and nutrition disorders     
Appetite Decreased   1/28 (3.57%)  1 1/30 (3.33%)  1
Appetite Increased   2/28 (7.14%)  2 5/30 (16.67%)  5
Abdominal Discomfort   1/28 (3.57%)  1 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Ache   2/28 (7.14%)  2 0/30 (0.00%)  0
Back Pain   3/28 (10.71%)  4 2/30 (6.67%)  2
Muscle Cramp   1/28 (3.57%)  1 0/30 (0.00%)  0
Drooling   0/28 (0.00%)  0 1/30 (3.33%)  1
Jaw Pain   0/28 (0.00%)  0 1/30 (3.33%)  1
Joint Pain   1/28 (3.57%)  2 0/30 (0.00%)  0
Knee Pain   1/28 (3.57%)  1 1/30 (3.33%)  1
Muscle Cramp   1/28 (3.57%)  1 3/30 (10.00%)  3
Muscle Spasm/Twitch   2/28 (7.14%)  3 1/30 (3.33%)  1
Muscle Weakness/Fatigue   0/28 (0.00%)  0 1/30 (3.33%)  1
Pain   0/28 (0.00%)  0 1/30 (3.33%)  1
Foot Pain   1/28 (3.57%)  1 0/30 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cyst   0/28 (0.00%)  0 1/30 (3.33%)  1
Nervous system disorders     
Concentration Impaired   0/28 (0.00%)  0 2/30 (6.67%)  2
Impaired Coordination   1/28 (3.57%)  1 1/30 (3.33%)  1
Decreased Sleep   0/28 (0.00%)  0 1/30 (3.33%)  1
Difficulty Thinking   1/28 (3.57%)  1 1/30 (3.33%)  1
Dizziness   1/28 (3.57%)  1 1/30 (3.33%)  1
Dizziness Upon Standing   1/28 (3.57%)  1 0/30 (0.00%)  0
Drowsiness   2/28 (7.14%)  2 0/30 (0.00%)  0
Drowsy on Awakening   1/28 (3.57%)  1 0/30 (0.00%)  0
Falling Down   0/28 (0.00%)  0 1/30 (3.33%)  1
False Sensation   0/28 (0.00%)  0 2/30 (6.67%)  2
Fatigue   1/28 (3.57%)  1 4/30 (13.33%)  5
Headache   2/28 (7.14%)  3 5/30 (16.67%)  6
Insomnia   0/28 (0.00%)  0 1/30 (3.33%)  1
Loss of Consciousness   0/28 (0.00%)  0 1/30 (3.33%)  1
Memory Impaired   1/28 (3.57%)  1 2/30 (6.67%)  2
Mental Concentration Difficulty   0/28 (0.00%)  0 1/30 (3.33%)  1
Mental Dullness   0/28 (0.00%)  0 1/30 (3.33%)  1
Nightmares   2/28 (7.14%)  3 4/30 (13.33%)  4
Numbness   0/28 (0.00%)  0 1/30 (3.33%)  1
Psychiatric disorders     
Apathy   1/28 (3.57%)  1 0/30 (0.00%)  0
Auditory Hallucinations   1/28 (3.57%)  1 0/30 (0.00%)  0
Depression   1/28 (3.57%)  2 0/30 (0.00%)  0
Feeling Strange   0/28 (0.00%)  0 1/30 (3.33%)  1
Hallucinations   2/28 (7.14%)  2 1/30 (3.33%)  1
Irritability   3/28 (10.71%)  3 5/30 (16.67%)  5
Nervousness   0/28 (0.00%)  0 3/30 (10.00%)  3
Panic Attack   0/28 (0.00%)  0 1/30 (3.33%)  1
Paranoia   1/28 (3.57%)  1 0/30 (0.00%)  0
Reproductive system and breast disorders     
Anorgasmia   2/28 (7.14%)  2 0/30 (0.00%)  0
Libido Decreased   1/28 (3.57%)  1 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders     
Coughing   0/28 (0.00%)  0 1/30 (3.33%)  1
Hyperventilation   0/28 (0.00%)  0 1/30 (3.33%)  1
Lung Disease Obstruvtive   0/28 (0.00%)  0 1/30 (3.33%)  1
Skin and subcutaneous tissue disorders     
Blisters   1/28 (3.57%)  1 0/30 (0.00%)  0
Bruise   1/28 (3.57%)  1 0/30 (0.00%)  0
Burning Skin   0/28 (0.00%)  0 1/30 (3.33%)  1
Dry Skin   1/28 (3.57%)  1 0/30 (0.00%)  0
Skin Irritation   0/28 (0.00%)  0 1/30 (3.33%)  1
Social circumstances     
Incarceration   0/28 (0.00%)  0 1/30 (3.33%)  1
Vascular disorders     
Chest Pain   1/28 (3.57%)  1 1/30 (3.33%)  1
Faintness   0/28 (0.00%)  0 1/30 (3.33%)  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
Name/Title: Principal Investigator
Organization: NYU Langone Health
Phone: 646-754-4843
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01981759     History of Changes
Other Study ID Numbers: 12-02991
First Submitted: October 29, 2013
First Posted: November 13, 2013
Results First Submitted: June 8, 2018
Results First Posted: July 9, 2018
Last Update Posted: April 11, 2019